American Contract Systems Inc Recall 94765
Description: TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
American Contract Systems Inc Recall 94765 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2275-2024 |
| Event ID | 94765 |
| Event Description | TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 66 units |
| Recall Reason | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| Device Classification | 20240717 |
| Device Code Info | UDI-DI: 00191072214553 LOT#"s: 968241 |
| Center Classification Date | 20240705 |
| Recall Initiation Date | 20240515 |
| Recalling Firm | American Contract Systems Inc |
| Initial Notification | |
| Similar To |