American Contract Systems Inc: Device Recall

Recall #Z-2302-2024 · 05/15/2024

Class II: Risk

Recall Details

Recall Number: Z-2302-2024
Classification: Class II
Product Type: Device
Recalling Firm: American Contract Systems Inc
Status: Ongoing
Date Initiated: 05/15/2024
Location: Tiffin, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 85 units

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.

Product Description

TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C

Distribution Pattern

US Nationwide distribution.

Other Recalls by American Contract Systems Inc

Class II: Risk 09/04/2025

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II: Risk 09/04/2025

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II: Risk 09/04/2025

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II: Risk 09/04/2025

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Class II: Risk 09/04/2025

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

View all recalls by American Contract Systems Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.