Implants & Prosthetics

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.

The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.

Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.

Firm become aware of reports of post-operative refractive errors following implantation of lenses.

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

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

GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclear Magnetic Resonance Imaging System, normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.

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.

The back cap separates from the body of the vitrectomy cutter.