Howmedica Osteonics Corp. Recall 93687
Description: PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
Howmedica Osteonics Corp. Recall 93687 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0914-2024 |
| Event ID | 93687 |
| Event Description | PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031 |
| Product Type | Devices |
| Distribution | Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. |
| Recall Reason | 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. |
| Device Classification | 20240207 |
| Device Code Info | GTIN: 04546540306920 Lot Numbers: 36273601, 36609701 |
| Center Classification Date | 20240131 |
| Recall Initiation Date | 20231201 |
| Recalling Firm | Howmedica Osteonics Corp. |
| Initial Notification | Letter |
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