Recall Z-2553-2016 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Stanmore Implants Worldwide Ltd.
METS SMILES Total Knee Replacement
| Date | Aug 17, 2016 (initiated May 31, 2016) |
| Status | Terminated |
| Reason | The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation. |
| Root cause | Device Design |
| Action | The recalling firm sent recall notification letters to their consignees on 05/31/2016. Follow up communciation was sent out on 7/26/2016 after a technical and medical assessment was completed. |
| Quantity | 3 units |
| Distribution | Directly distributed to TX, further distributed to AL and MS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120992 | METS SMILES TOTAL KNEE REPLACEMENT Stanmore Implants Worldwide , Ltd., Sep 5, 2012 |