ðĨ Medical Devices âĒ 4,589 recalls
Windstone Medical Packaging
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue sleeve has too much clearance with new revision targeting arm. Risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another Recon Targeting Arm or Recon Soft tissue Sleeve is located or while the surgeon completes the procedure by hand.
GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command.
Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue sleeve has too much clearance with new revision targeting arm. Risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another Recon Targeting Arm or Recon Soft tissue Sleeve is located or while the surgeon completes the procedure by hand.
CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it could increase the risk of patient burn.
Zimmer Biomet
The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened. The bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Product was incorrectly packaged.
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Abbott Medical Optics Inc. (AMO)
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Abbott Medical Optics Inc. (AMO)
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Abbott Medical Optics Inc. (AMO)
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.