Recall Z-1692-2017 ยท LXH Orthopedic Manual Surgical Instrument
United Orthopedic Corporation
UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
| Date | Mar 1, 2017 (initiated Feb 10, 2017) |
| Status | Terminated |
| Reason | The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable. |
| Root cause | Device Design |
| Action | United Orthopedic Corporation sent an Urgent Field Safety Notice dated January 19, 2017, to all affected consignees via e-mail on February 10. 2017. The Urgent Field Safety Notice instructed consignees to recover any affected units and return them to the manufacturer. A redesigned device will be sent for replacements. Consignees with questions were instructed to call 949-328-3366. |
| Quantity | 33 units |
| Distribution | Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.