Total Knee Procedure Kit Recalled for Excess Ethylene Oxide Residue
American Contract Systems Inc is recalling a knee surgery procedure kit (24 units, Lot 939241) due to ethylene oxide sterilization residues in the cast padding exceeding safety exposure limits for permanent-implant devices.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where sterilization residuals exceeded regulatory exposure limits per ANSI/AAMI/ISO standards for permanent-implant devices. The recall is based on technical violation of chemical exposure limits rather than reported harm.
Plain-English summary
American Contract Systems Inc is recalling the TOTAL KNEE 297835 Procedure Kit (Catalog Number RGTK10L) distributed nationwide. The recall affects 24 units with Lot 939241. The kit is used in total knee replacement surgical procedures.
Testing of the product's cast padding component revealed that residual levels of ethylene oxide and ethylene chlorohydrin exceeded the exposure limits set by ANSI/AAMI/ISO 10993-7:2012 standards for devices intended for permanent implantation in patients. These chemicals are sterilization byproducts.
Patients and healthcare providers who have received this product should contact American Contract Systems Inc immediately. Healthcare facilities should discontinue use of affected units and arrange return or replacement.
The recalled product
- Product
- TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide-residue
- chemical-exposure
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: 00191072216182 LOT#"s: 939241
Distribution
Distributed nationwide across the United States.
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