Medical equipment, implants, and diagnostic devices
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Potential interference with the anti-fall system.
Allergan Sales
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
RAYSEARCH LABORATORIES AB
Potential for reported SSD to be too high.
Olympus Corporation of the Americas
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
IVOCLAR VIVADENT AG
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
RAYSEARCH LABORATORIES AB
Potential for reported SSD to be too high.
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Cardinal Health 200
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
RAYSEARCH LABORATORIES AB
Potential for reported SSD to be too high.
Advanced Research Medical
Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
IVOCLAR VIVADENT AG
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Medtronic Neuromodulation
inability to reprogram one device
RAYSEARCH LABORATORIES AB
Potential for reported SSD to be too high.
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention