Recall Z-1255-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551
| Date | Apr 7, 2010 (initiated Feb 22, 2010) |
| Status | Terminated |
| Reason | One lot of product was incorrectly manufactured. Pegs are larger than specification. |
| Root cause | Process control |
| Action | Firm notified consignees by e-mail on 2/22/2010. |
| Quantity | 2 units |
| Distribution | United States (FL and ID). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932246 | FOUNDATION METAL-BACKED PATELLA Encore Orthopedics, Inc., Jul 22, 1994 |