Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
FDA device recall Z-1778-2022 · posted 2022-09-23 · Open, Classified
Recall details
- Recalling firm
- Howmedica Osteonics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- KRQ
- Quantity affected
- 1 unit
- Distribution
- Distributed to one customer located in New York.
- Date initiated
- 2022-08-24
- Date posted
- 2022-09-23
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PATIENT SPECIFIC DISTAL FEMORAL (K140898) | Stanmore Implants Worldwide , Ltd. | 2015-01-20 |