Recall Z-0775-2018 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
| Date | Sep 13, 2017 |
| Status | Terminated |
| Reason | Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail. |
| Root cause | Device Design |
| Action | On September 13, 2017 an URGENT MEDICAL DEVICE RECALL REMOVAL was issued to customers requesting that they review inventory and quarantine affected product, which will be immediately returned to recalling firm. Also to notify any customers who may have received product. Questions or concerns can be directed to Customer Service at 574-371-3071 |
| Quantity | 337 total |
| Distribution | Distribution includes US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.