Howmedica Osteonics Corp. Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Brand
Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Lot number B24694 (no UDI)
Products Sold
Lot number B24694 (no UDI)
Howmedica Osteonics Corp. is recalling Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component. due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, NY
Page updated: Jan 10, 2026