Recall archive / FDA device enforcement
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component. — FDA record Z-1778-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 24, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
- 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.
- Classification
- Class II
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1778-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot number B24694 (no UDI) |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed to one customer located in New York.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 5, 2022
- Recall initiation date
- Aug 24, 2022
- Center classification date
- Sep 23, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.