ðĨ Medical Devices âĒ 4,540 recalls
Medtronic Sofamor Danek USA
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
Medtronic Sofamor Danek USA
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.
78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
Medtronic Sofamor Danek USA
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Medtronic Sofamor Danek USA
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Medtronic Sofamor Danek USA
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Biomet 3i
Pouches may not have been sealed during packing.
Biomet 3i
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.
Biomet 3i
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.
Biomet 3i
Pouches may not have been sealed during packing.