Howmedica Osteonics Corp. Recall 93687
Description: SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
Howmedica Osteonics Corp. Recall 93687 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0897-2024 |
| Event ID | 93687 |
| Event Description | SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710 |
| 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. |
| Quantity | 118 units US; 212 units OUS |
| 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: 07613327033908 Lot Numbers: RNT5, 3YNP, PEA1, NNA5, 5A2R, 98AH, T1JH, 8D72, E0VH, 3PA0, 05L4, R608 |
| Center Classification Date | 20240131 |
| Recall Initiation Date | 20231201 |
| Recalling Firm | Howmedica Osteonics Corp. |
| Initial Notification | Letter |
| Similar To |