American Contract Systems recalls TOTAL KNEE procedure tray (BFTK01AA) due to potential EO/ECH residues exceeding safety limits. Affected units may pose injury risk during long-term 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 trays with catalog number BFTK01AA because ethylene oxide/ethylene chlorohydrin residues may exceed safe levels for long-term use. This could potentially cause injury if the tray is used for extended periods.
Ethylene oxide and ethylene chlorohydrin residues in the tray may exceed safe exposure limits over time. This could potentially cause injury to healthcare workers or patients during prolonged use of the device.
Healthcare professionals using the TOTAL KNEE procedure tray for surgical procedures are most at risk. Patients receiving long-term care from this device may also be affected.
Check for catalog number BFTK01AA on the tray. The product was sold with lot numbers 922241 and UDI-DI: 00191072215970.
Verify the catalog number on the tray is BFTK01AA and lot number 922241.
The recall indicates potential safety concerns with long-term use, but the product may be safe for short-term use. Consult the official recall notice for full details.
The recall does not specify a remedy, so contact American Contract Systems for guidance.
Look for catalog number BFTK01AA and lot number 922241 on the tray.
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-2278-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2278-2024 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.
