Biomet, Inc.: Medical Device Recalls in 2016

According to to data from the FDA, there were 22 medical device recalls made by Biomet, Inc. in 2016. See the details of the recalls below.

You can see similar recalls for other firms.

• Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
• Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.
• TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies
• PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
• Various trauma and sports medicine instruments and implants. Reamer.
• Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
• Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
• Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.
• All instrumentation associated with the Prelude PF Resurfacing Knee System.
• Various trauma and sports medicine instruments and implants. Bit, drill.
• Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
• Various trauma and sports medicine instruments and implants. Passer.
• Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.
• Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
• Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
• Various trauma and sports medicine instruments and implants. Plate, fixation, bone.
• Various trauma and sports medicine instruments and implants. guide, surgical, instrument
• Various trauma and sports medicine instruments and implants. Arthroscope.
• Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
• Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
• HipLOC CHS Plate/Lag Screw Introducer
• Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm