Recall Z-2163-2018 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Smith & Nephew, Inc.
smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
| Date | May 4, 2018 |
| Status | Terminated |
| Reason | One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification. |
| Root cause | Error in labeling |
| Action | The firm initiated the recall by email on 05/04/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return. |
| Quantity | 5 units |
| Distribution | International only: United Arab Emirates, Spain, Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121393 | SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION Smith & Nephew, Inc., Aug 7, 2012 |