Medical equipment, implants, and diagnostic devices
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
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
One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged 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
RAYSEARCH LABORATORIES AB
Potential for reported SSD to be too high.
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.
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
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.
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
Abbott Medical
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
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
ROUTE 92 MEDICAL
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
ROUTE 92 MEDICAL
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Baxter Healthcare
Product was distributed in the United States without proper regulatory approval.
Howmedica Osteonics
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Howmedica Osteonics
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.