American Contract Systems recalls TOTAL KNEE Procedure Kit (QPTK95A) due to excessive ethylene oxide residuals in cast padding, potentially causing skin irritation. Affected units include specific lot numbers.
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 QPTK95A) because ethylene oxide residues in the cast padding may cause skin irritation. This recall affects medical devices used in knee surgeries.
The cast padding in the kit contains ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for long-term exposure. These chemicals can cause skin irritation when the padding is in contact with skin during surgery.
Medical professionals who use this knee procedure kit during surgery are most at risk. Patients receiving the kit may experience skin irritation if residues are not properly removed.
Check for the catalog number QPTK95A on the kit. Affected units include specific lot numbers: 968241 and 922241. The kit was sold with UDI-DI: 00191072201: 1225.
Look for catalog number QPTK95A and lot numbers 968241 or 922241 on the kit.
The recall is for potential skin irritation from ethylene oxide residues, which is a low-risk hazard.
Check for catalog number QPTK95A and lot numbers 968241 or 922241 on the kit.
The recall does not specify a remedy, so contact American Contract Systems for guidance.
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-2293-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2293-2024 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.
