Recall Z-3264-2018 ยท JDO Device, Fixation, Proximal Femoral, Implant
Biomet UK Ltd.
HipLOC Hip Fracture Fixation System-Hiploc System 140 Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtroc
| Date | Aug 9, 2018 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Process design |
| Action | Zimmer Biomet issued US recall notices issued on August 9, 2018 via email and FedEx to Distributors and Hospitals advising of the problem and instruction to remove and return.Your Zimmer Biomet sales representative will remove the affected product from your facility. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.comnistructions.mailto:CorporateQQuality.PostMarket@zimmerbiomet.com. |
| Quantity | 6 units |
| Distribution | US Nationwide in the states of AZ, MO, NJ and NM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080685 | HIPLOC COMPRESSION HIP SCREW Biomet Manufacturing, Inc., Aug 15, 2008 |