Drug recall
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
FDA recall event 90836 · Class II · Howmedica Osteonics Corp.
Key facts
| Event ID | 90836 |
|---|---|
| Recall numbers | Z-1778-2022 |
| Recalling firm | Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 24, 2022 |
| Report date | Oct 5, 2022 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3003070421 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: