Recall Z-0305-05 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Smith & Nephew Inc
Tibial Base Plates
| Date | Dec 14, 2004 (initiated Jun 21, 2004) |
| Status | Terminated |
| Reason | The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively. |
| Root cause | Other |
| Action | Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email) on 06/21/2004 to request the return of any in stock product. |
| Quantity | 11,339 units were distributed |
| Distribution | Nationwide, 43 consignees, 17 countries: Germany, France, Australia, Italy, Switzerland, United Arab Emirates, Belgium, Japan, United Kingdom, Singapore, Spain, Taiwan. Sweden, Canada Venezuela, South Africa, and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912735 | GENESIS UNICOMPARTMENTAL KNEE SYSTEM Smith & Nephew Richards, Inc., Dec 27, 1991 |