Knee Surgery Procedure Kit Recalled for Ethylene Oxide Residue
American Contract Systems Inc recalled a knee surgery procedure kit (Catalog RGTK10K) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits on the cast padding component.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is chemical residuals exceeding established safety standards, constituting a precautionary compliance issue rather than documented harm.
Plain-English summary
American Contract Systems Inc is recalling the TOTAL KNEE 297835-Procedure Kit (Catalog Number RGTK10K) distributed nationwide. The recall affects 24 units with Lot 665231.
The cast padding component of the procedure kit contained ethylene oxide and ethylene chlorohydrin residuals that exceeded the safety limits specified in the ANSI/AAMI/ISO 10993-7/(R)2012 standard for permanent-exposure medical devices.
Healthcare facilities and providers should stop using these kits immediately and contact American Contract Systems Inc for return or replacement instructions. Facilities should identify any patients who received procedures using the affected units.
The recalled product
- Product
- TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide-residue
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: 00191072203267 LOT#"s: 665231
Distribution
Distributed nationwide across the United States.
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