American Contract Systems recalls TOTAL KNEE Procedure Kit (Catalog RGTK10L) due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, which could cause injury 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 TOTAL KNEE Procedure Kit (Catalog RGTK1: 00191072216182) because ethylene oxide/ethylene chlorohydrin residuals in the cast padding may cause injury with prolonged use. This affects kits sold with specific lot numbers.
The cast padding in the kit contains ethylene oxide and ethylene chlorohydrin residuals that exceed safety limits for long-term use. These chemicals can cause injury if the padding is in contact with skin for extended periods during medical procedures.
Healthcare professionals using the TOTAL KNEE Procedure Kit for surgical procedures are most at risk due to potential prolonged exposure to residuals. Patients receiving the kit are less likely to be affected directly.
Check for the catalog number RGTK10L on the kit. The UDI-DI is 00191072216182 and lot numbers include 939241. This kit was sold with specific lot numbers.
Look for the catalog number RGTK10L and UDI-DI 00191072216182 on the kit packaging.
The recall is for potential injury from prolonged exposure to ethylene oxide/ethylene chlorohydrin residuals in the cast padding, but the risk is low for most users.
Check for the catalog number RGTK10L and UDI-DI 00191072216182 on the kit packaging. Lot numbers include 939241.
The recall does not specify a remedy, so no action is required beyond checking if you have the kit.
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-2297-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2297-2024 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.
