Short tibial bearing MK4 — Class II medical device recall Z-1778-2022
Ongoing recall by Howmedica Osteonics Corp., reported 2022-10-05, distributed in NY. A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, th
| Recall number | Z-1778-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2022-08-24 |
| Classified | 2022-09-23 |
| Reported by FDA | 2022-10-05 |
| Distributed | NY |
| Quantity | 1 units |
| Lot numbers | B24694 |
| Model numbers | SMMLTB02 |
Product
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1778-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.