American Contract Systems Inc Recall: TOTAL KNEE - 302497- Procedure tray Catalog Number:
American Contract Systems Inc Recall: TOTAL KNEE - 302497- Procedure tray Catalog Number: is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: American Contract Systems Inc; Product: TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF; Reason for recall: Ethylene Oxide/Ethylene Chl
| Recalling firm | American Contract Systems Inc |
|---|---|
| Product | TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US Nationwide distribution. |
| Recall initiated | 20240515 |
| Recall number | Z-2275-2024 |
| Category | device |
| State | OH |
| Country | United States |
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