Recall Z-1712-2014 ยท LXH Orthopedic Manual Surgical Instrument
Microport Orthopedics INC.
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
| Date | Jun 4, 2014 (initiated Apr 30, 2014) |
| Status | Terminated |
| Reason | Difficulty removing the cup adaptor from the impaction handle during surgery |
| Root cause | Device Design |
| Action | Firm has initiated the recall by email on 04/28/2014 to all distributor's offices, including international, then followed with written communication on 05/02/2014 via Fed Ex P1 delivery to all United States consignees. Follow-up to non-responding consignees will commence 30 days after initiation. |
| Quantity | 140 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.