Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
This recall is currently active, issued September 23, 2022. It was issued by Howmedica Osteonics Corp..
- Company
- Howmedica Osteonics Corp.
- Recall Initiated
- August 24, 2022
- Posted
- September 23, 2022
- Recall Number
- Z-1778-2022
- Quantity
- 1 unit
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed to one customer located in New York.
Lot / Code Info
Lot number B24694 (no UDI)
Root Cause
Under Investigation by firm
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.