American Contract Systems recalls TOTAL KNEE Procedure Kit (Catalog RGTK10K) due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, potentially causing tissue damage with prolonged use.
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.
American Contract Systems is recalling their TOTAL KNEE Procedure Kit (Catalog Number RGTK1: 297835) because ethylene oxide and ethylene chlorohydrin residues in the cast padding may cause tissue damage with long-term use. This recall affects kits sold with specific lot numbers and UDI-DI codes.
The cast padding in the kit contains ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for long-term use. These chemicals can cause tissue damage if the padding remains in contact with the body for extended periods.
Healthcare professionals using the TOTAL KNEE Procedure Kit for surgical procedures are most at risk. Patients receiving the kit for knee surgeries may also be affected if the residues cause tissue damage.
Check for the catalog number RGTK10K on the kit label. The UDI-DI code 00191072203267 and lot numbers 665231 indicate the recalled items.
Look for the catalog number RGTK10K and UDI-DI code 00191072203267 on the kit packaging.
The recall is for healthcare professionals using the kit; patients receiving the surgery may be at risk if the residues cause tissue damage with prolonged use.
The official recall notice does not specify a remedy or action steps beyond checking the kit label for the catalog number and UDI-DI code.
Recalled kits have catalog number RGTK10K, UDI-DI code 00191072203267, and lot number 665231.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2296-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2296-2024 from American Contract Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
