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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 firmAmerican Contract Systems Inc
ProductTOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
Reason for recallEthylene 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionUS Nationwide distribution.
Recall initiated20240515
Recall numberZ-2275-2024
Categorydevice
StateOH
CountryUnited States

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