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 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
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 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
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 ...
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 ...
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 endplate...
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...
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 attainm...
Source: Medical Device Recalls - April 23, 2015 Category: Medical Equipment Source Type: alerts
