Exactech, Inc. - Opteform Allograft Disc - Class 2 Recall
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 30, 2019 Category: Medical Devices Source Type: alerts

Exactech, Inc. - Opteform Allograft Disc - Class 2 Recall
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 30, 2019 Category: Medical Devices Source Type: alerts

Exactech, Inc. - Opteform Allograft Disc - Class 2 Recall
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 30, 2019 Category: Medical Devices Source Type: alerts

Bioventus, LLC - Bioactive Bone Graft Putty - Class 2 Recall
BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 16, 2019 Category: Medical Devices Source Type: alerts

Medtronic Sofamor Danek USA Inc - INFUSE Bone Graft X SMALL KIT - Class 2 Recall
INFUSE Bone Graft X SMALL KIT REF 7510100 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

Integrity Implants Inc. - FlareHawk - Class 2 Recall
FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 8, 2018 Category: Medical Devices Source Type: alerts

Stryker Spine - AVS Aria Cage - Class 2 Recall
AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 11, 2018 Category: Medical Devices Source Type: alerts

Neuropro Spinal Jaxx - Spinal Jaxx Interbody Fusion Device - Class 2 Recall
Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jax...
Source: Medical Device Recalls - April 11, 2018 Category: Medical Devices Source Type: alerts

Howmedica Osteonics Corp. - ORTHOPEDIC MANUAL SURGICAL INSTRUMENT - Class 2 Recall
AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in the anterior portion of the intervertebral space, and then through activation of the rotational pivot between the Handle and implant for final placement of the crescent-shaped cage across the anterior portion of the disc space. The AccuLIF TL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of canc...
Source: Medical Device Recalls - March 2, 2018 Category: Medical Devices Source Type: alerts

Terumo BCT, Inc. - HARVEST TERUMOBCT, GCP10 Graft Delivery Pack - Class 2 Recall
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2017 Category: Medical Devices Source Type: alerts

Alphatec Spine, Inc. - Arsenal Spinal Fixation System - Class 2 Recall
Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available i...
Source: Medical Device Recalls - June 7, 2017 Category: Medical Devices Source Type: alerts

XTANT MEDICAL INC - Fortex Pedicle Screw System - Class 2 Recall
5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sac...
Source: Medical Device Recalls - April 28, 2017 Category: Medical Equipment Source Type: alerts

Kiscomedica S.A. - LVarlock Cage/Trial Implant Holder - Class 2 Recall
L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-V...
Source: Medical Device Recalls - February 28, 2017 Category: Medical Equipment Source Type: alerts

Interventional Spine Inc - G3 Opticage Expandable Interbody Fusion Device - Class 2 Recall
G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with deg...
Source: Medical Device Recalls - January 4, 2017 Category: Medical Equipment Source Type: alerts

Amendia, Inc - Black Widow Buttress Plate and Screw - Class 2 Recall
Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2016 Category: Medical Equipment Source Type: alerts

Amendia, Inc - Black Widow Buttress Plate and Screw - Class 2 Recall
Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2016 Category: Medical Equipment Source Type: alerts

Alphatec Spine, Inc. - Class 2 Recall
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are avail...
Source: Medical Device Recalls - November 17, 2016 Category: Medical Equipment Source Type: alerts

Howmedica Osteonics Corp. - Stryker AccuLIF PL Cages - Class 2 Recall
AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerati...
Source: Medical Device Recalls - September 13, 2016 Category: Medical Equipment Source Type: alerts

Howmedica Osteonics Corp. - Stryker AccuLIF PL Cages - Class 2 Recall
AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerat...
Source: Medical Device Recalls - September 13, 2016 Category: Medical Equipment Source Type: alerts

Howmedica Osteonics Corp. - Stryker AccuLIF PL Cages - Class 2 Recall
AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerativ...
Source: Medical Device Recalls - September 13, 2016 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corporation - Integra - Class 2 Recall
Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. Integra template is indicated for the postexcisional treatment of life-threatening...
Source: Medical Device Recalls - September 10, 2016 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Oblique Posterior Atraumatic Lumbar (OPAL) System - Class 2 Recall
Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be sk...
Source: Medical Device Recalls - April 15, 2016 Category: Medical Equipment Source Type: alerts

Biomet Spine, LLC - Solitaire Anterior Spinal System - Class 2 Recall
10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-...
Source: Medical Device Recalls - March 26, 2016 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - Exactech Acapella One Interbody Fusion Device Parallel - Class 2 Recall
Exactech Acapella One Interbody Fusion Device Parallel Product Usage: The Acapella TM One cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2016 Category: Medical Equipment Source Type: alerts

Stryker Spine - Stryker Radius Spinal System - Class 2 Recall
Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 13, 2015 Category: Medical Equipment Source Type: alerts

Biomet Spine, LLC - MaxAn 4.0mm and 4.5mm fixed screw - Class 2 Recall
MaxAn 4.0mm and 4.5mm fixed screws are used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervial Plate System is a decompression-based technique for cervical spine stabilization and introduces an innovative one-level plate technique that provides a direct relationship between the bone graft/spacer size and the position of the plate holes. The unique ability to obtain maximum screw angulation and place a fixed screw at any angle up to 30 degrees cephaled on the superior end of the plate and up to 30 degrees caudal on the inferior end of the plate allows for versatile screw placement close to the endplates...
Source: Medical Device Recalls - November 4, 2015 Category: Medical Equipment Source Type: alerts

TITAN SPINE, LLC - Endoskeleton Locking Bone Screw Assembly - Class 2 Recall
Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws. The Endoskeleton¿ TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton¿ TCS IBD implants are intended for treatme...
Source: Medical Device Recalls - August 4, 2015 Category: Medical Equipment Source Type: alerts

Musculoskeletal Transplant Foundation, Inc. - Musculoskeletal Transplant Foundation Allofix Insertion Kit - Class 2 Recall
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 16, 2015 Category: Medical Equipment Source Type: alerts

CRYOLIFE, INC. - Class 2 Recall
Cryolife Valve Allograft. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2015 Category: Medical Equipment Source Type: alerts

X Spine Systems Inc - Xpress System Pedicle Screw Assembly, 5.5 x 55mm - Class 2 Recall
Xpress System Pedicle Screw Assembly, 5.5 x 55mm . is an internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies. Each Xpress pedicle screw assembly consists of a pedicle screw, yoke, screw top and threaded setscrew. The Xpress Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment ...
Source: Medical Device Recalls - April 23, 2015 Category: Medical Equipment Source Type: alerts

Spinal Elements, Inc - TiBond - Class 2 Recall
Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 6, 2015 Category: Medical Equipment Source Type: alerts

Ebi, Llc - SolitaireC Cervical Spacer System - Class 2 Recall
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 25, 2014 Category: Medical Equipment Source Type: alerts

Biomet Spine LLC. - Biomet Spine Durango Anchored ALIF Plate - Class 2 Recall
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2014 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. - Accell Evo3c Demineralized Bone Matrix Putty - Class 2 Recall
Accell¿ Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2014 Category: Medical Equipment Source Type: alerts

Synthes, Inc. - Synthes XRL Medium TrialCentral Body - Class 2 Recall
Synthes XRL Medium Trial-Central Body Synthes XRL Medium Trial-Central Body is used as part of the Synthes XRL System and is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e.fracture). The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX,Pangea, and TSLP). The interior of the Synthes XRL can be packed with bone (i.e. autograft or allograft). It is designed to provide anterior spinal column support even in the absence of ...
Source: Medical Device Recalls - June 3, 2014 Category: Medical Equipment Source Type: alerts

AlloSource, Inc. - AlloFuse DBM Putty 5cc - Class 2 Recall
AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AllFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2014 Category: Medical Equipment Source Type: alerts

RTI Surgical, Inc. - OPTEFORM Allograft Paste - Class 2 Recall
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 8, 2014 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - InteGrip Acetabular Augment - Class 2 Recall
***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 4, 2014 Category: Medical Equipment Source Type: alerts

RTI Surgical, Inc. - CPlus - Class 2 Recall
C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and autograft. These implants are manufactured from PEEK (Polyaryletheretherketone) polymer with tantalum marker pins for radiographic visualization. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2014 Category: Medical Equipment Source Type: alerts

Ebi, Llc - Biomet The Polaris Spinal System; Shortened Plug Driver - Class 2 Recall
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with dege...
Source: Medical Device Recalls - November 28, 2013 Category: Medical Equipment Source Type: alerts

Lanx, Inc. - Timberline MPF Straight Split Tip Driver Short (Driver) - Class 2 Recall
LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a c...
Source: Medical Device Recalls - November 27, 2013 Category: Medical Equipment Source Type: alerts

Stryker Spine - Stryker Spine Torque Wrench - Class 2 Recall
Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterloateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment ...
Source: Medical Device Recalls - November 22, 2013 Category: Medical Equipment Source Type: alerts

Globus Medical, Inc. - MicroFuse Bone Void Filler - Class 2 Recall
Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2013 Category: Medical Equipment Source Type: alerts

Harvest Technologies Corporation - Graft Delivery System - Class 2 Recall
Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 18, 2013 Category: Medical Equipment Source Type: alerts

Alphatec Spine, Inc. - lllico Ti Cannulated Polyaxial Screw - Class 2 Recall
lllico Ti Cannulated Polyaxial Screw 7.5mm X 40mm It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft. It is intended that this device, in any system configuration, be removed after development of solid fusion mass. The lllico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. K123623 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 28, 2013 Category: Medical Equipment Source Type: alerts

Synthes USA HQ, Inc. - Class 2 Recall
Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 18, 2013 Category: Medical Equipment Source Type: alerts

SpineFrontier, Inc. - SLIFT - Class 2 Recall
S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 6, 2013 Category: Medical Equipment Source Type: alerts

Medtronic Sofamor Danek USA Inc - INFUSE(R) Bone Graft - Class 2 Recall
INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2013 Category: Medical Equipment Source Type: alerts

Medtronic Sofamor Danek USA Inc - INFUSE(R) Bone Graft - Class 2 Recall
INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2013 Category: Medical Equipment Source Type: alerts

Medtronic Sofamor Danek USA Inc - INFUSE(R) Bone Graft - Class 2 Recall
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2013 Category: Medical Equipment Source Type: alerts