Recall Z-1778-2022 ยท KRQ Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
Howmedica Osteonics Corp.
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
| Date | Sep 23, 2022 (initiated Aug 24, 2022) |
| Status | Open, Classified |
| Reason | A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing. |
| Root cause | Under Investigation by firm |
| Action | On August 24, 2022, the firm sent written notification (Product Field Action) to the single affected customer to document the event. The customer was asked to confirm their receipt of the notice. |
| Quantity | 1 unit |
| Distribution | Distributed to one customer located in New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140898 | PATIENT SPECIFIC DISTAL FEMORAL Stanmore Implants Worldwide , Ltd., Jan 20, 2015 |