Recall Z-2883-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
| Date | Aug 1, 2017 |
| Status | Terminated |
| Reason | Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left. |
| Root cause | Employee error |
| Action | The firm notified its consignees of the problem and the recall by email on 08/01/2018. The firm requested the return of the product. |
| Quantity | 27 units |
| Distribution | Australia, Austria, Germany, Great Britain, Poland, Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951987 | GENESIS II TOTAL KNEE SYSTEM Smith & Nephew Richards, Inc., Aug 22, 1995 |