Recall Z-0867-2007 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Wright Medical Technology Inc
Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only Hip implant.
| Date | Jun 7, 2007 (initiated Mar 27, 2007) |
| Status | Terminated |
| Reason | The titanium plasma coating was found to have missing fragments. |
| Root cause | Other |
| Action | The firm sent out recall notices to implanting surgeons by letter dated 03/27/2007 (via FedEx) to notify the surgeons of the issue. The hospitals and distributors were also notified of the issue and given instructions for return of the product. |
| Quantity | 18 units |
| Distribution | Nationwide, Puerto Rico, & Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003016 | PRO-FEMUR R Wrightmedicaltechnologyinc, Dec 13, 2000 |