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, 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, 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 Ja...
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 can...
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 ...
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 sa...
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-...
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
