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Implants & Prosthetics

ðŸĨ Medical Devices â€Ē 4,540 recalls

HipLOC Hip Fracture Fixation System- Hiploc System 130Âŋ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

Biomet UK

Class I - Dangerous

HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel

Aug 9, 2018 Implants & Prosthetics Nationwide View Details →

PROPONENT Pacemaker

Boston Scientific

Class I - Dangerous

Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.

Sep 10, 2018 Implants & Prosthetics Nationwide View Details →

ACCOLADE Pacemaker

Boston Scientific

Class I - Dangerous

Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.

Sep 10, 2018 Implants & Prosthetics Nationwide View Details →

ESSENTIO Pacemaker

Boston Scientific

Class I - Dangerous

Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.

Sep 10, 2018 Implants & Prosthetics Nationwide View Details →

HipLOC Hip Fracture Fixation System-Hiploc System 135Âŋ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

Biomet UK

Class I - Dangerous

HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel

Aug 9, 2018 Implants & Prosthetics Nationwide View Details →

Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies. Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies.

Zimmer Biomet

Class I - Dangerous

The item is labeled as an 8.3mm, but it is actually a 12 mm.

Jul 30, 2018 Implants & Prosthetics View Details →
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