Howmedica Osteonics Corp. Recall 93687
Description: SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
Howmedica Osteonics Corp. Recall 93687 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0893-2024 |
| Event ID | 93687 |
| Event Description | SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110 |
| 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 | 107 units US; 176 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: 07613327033861 Lot Numbers: XEA7, 8P83, 690Y, MRM3, 67D4, 4902, YNP7, 3AYN, AYHM, W3MD, 76KN, K4P9, 792H, 43T8, MW40 |
| Center Classification Date | 20240131 |
| Recall Initiation Date | 20231201 |
| Recalling Firm | Howmedica Osteonics Corp. |
| Initial Notification | Letter |
| Similar To |