Knee Procedure Tray Recalled for Excess Sterilization Gas Residue
American Contract Systems is recalling TOTAL KNEE procedure trays because sterilization gas residuals on the cast padding component exceed regulatory safety limits. No injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving chemical residue exceeding regulatory limits with no reported illnesses or injuries. The hazard is preventive in nature rather than based on adverse event reports.
Plain-English summary
American Contract Systems Inc is recalling 66 units of the TOTAL KNEE-302497 procedure tray (Catalog Number ANTK12AF) from nationwide US distribution. The recall was issued due to ethylene oxide and ethylene chlorohydrin residuals on the cast padding component that exceed the acceptable limits specified in the ANSI/AAMI/ISO 10993-7 standard for permanent exposure medical devices.
Sterilization gas residuals that exceed regulatory limits may pose a potential risk of adverse reactions in patients who use or come into contact with the affected device. No illnesses or injuries have been reported to date.
Healthcare facilities that received affected trays should discontinue use and contact American Contract Systems Inc or their healthcare provider for instructions on returning or replacing the product.
The recalled product
- Product
- TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide-residue
- chemical-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00191072214553 LOT#"s: 968241
Distribution
Distributed nationwide across the United States.
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