Drug recall
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
FDA recall event 93687 · Class II · Howmedica Osteonics Corp.
Key facts
| Event ID | 93687 |
|---|---|
| Recall numbers | Z-0869-2024, Z-0870-2024, Z-0871-2024, Z-0872-2024, Z-0873-2024, Z-0874-2024, Z-0875-2024, Z-0876-2024, Z-0877-2024, Z-0878-2024, Z-0879-2024, Z-0880-2024 and 46 more |
| Recalling firm | Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709, DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911, DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200, DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609, DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611 and 52 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
| Initiation date | Dec 1, 2023 |
| Report date | Feb 7, 2024 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3003070421 |
At a glance
- 10–99 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: