American Contract Systems recalls TOTAL KNEE Procedure Kit (QPTK95B) due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, which may 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 Number QPTK95B) because ethylene oxide and ethylene chlorohy:drin residues in the cast padding exceed safety limits. This could cause injury if the kit is used for extended periods.
The cast padding in the kit contains higher-than-safe levels of ethylene oxide and ethylene chlorohydrin residues. These chemicals can cause injury if the padding is used for extended periods, especially during prolonged surgical procedures.
Healthcare professionals who use this surgical kit for knee procedures are most at risk. Patients receiving the kit for knee surgery may also be affected.
Check for the catalog number QPTK95B on the kit. The kit was sold with lot numbers starting with 911241. This product is used in knee surgery procedures.
Look for the catalog number QPTK95B and lot numbers starting with 911241 on the kit.
The recall is for potential injury from chemical residues in the cast padding, but the risk is low with proper use.
Check for catalog number QPTK95B and lot numbers starting with 911241 on the kit.
The recall does not specify a remedy, so contact American Contract Systems for further instructions.
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-2294-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2294-2024 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.
