FDA Device recall Z-1778-2022
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02
- FDA Device
- Class II
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02 by Howmedica Osteonics, citing 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 tibi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1778-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-24 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Howmedica Osteonics |
| Distribution | NY |
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.
Identifiers
| code_info | Lot number B24694 (no UDI) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1778-2022%22
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