American Contract Systems recalls TOTAL KNEE casts with catalog number LMTK17AP due to potential skin irritation from ethylene oxide residuals. Affected units include specific lot numbers and UDI-DI codes.
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 recalls TOTAL K:KNEE casts with catalog number LMT:KNEE LMTK17AP because ethylene oxide residuals may cause skin irritation. This affects specific lot numbers and UDI-DI codes.
Ethylene oxide and ethylene chlorohydrin residuals in the cast padding may cause skin irritation. This happens because the residuals exceed safety limits for permanent exposure devices as per ANSI/AAMI/ISO 10993-7 standards.
People who own or use TOTAL KNEE casts with catalog number LMTK17AP are affected. Those with skin sensitivity may be at higher risk.
Check for catalog number LMTK17AP on the cast. Look for specific lot numbers: 645231, 976241, or 918241. The UDI-DI code 00191072192172 is also associated with these units.
Look for catalog number LMTK17AP, lot numbers 645231, 976241, or 918241, and UDI-DI code 00191072192172 on the cast.
Ethylene oxide and ethylene chlorohydrin residuals in the cast padding may cause skin irritation, as the residuals exceed safety limits for permanent exposure devices.
Check if your cast has catalog number LMTK17AP and the specific lot numbers or UDI-DI code mentioned in the recall notice.
The recall indicates potential skin irritation from ethylene oxide residuals, but no specific injuries or deaths have been reported.
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-2290-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2290-2024 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.
