American Contract Systems recalls TOTAL KNEE Procedure tray (BFTK01Z) due to excessive ethylene oxide/ethylene chlorohydrin residuals potentially causing tissue damage. 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 is recalling their TOTAL KNEE Procedure tray (Catalog BFTK01Z) because ethylene oxide/ethylene chlorohydrin residues may cause tissue damage with prolonged contact. This risk applies to medical devices used in surgical procedures.
The procedure tray contains ethylene oxide or ethylene chlorohydrin residues that exceed safe levels for long-term contact with tissue. This could potentially cause tissue damage during surgical procedures if the device is not properly sterilized.
Healthcare professionals using the TOTAL KNEE Procedure tray in surgical settings are most at risk. Patients receiving the device during procedures may also be affected.
Check for the catalog number BFTK01Z and lot numbers 983241 on the tray. The unique device identifier (UDI-DI) 00191072214614 is also associated with this recall.
Look for the catalog number BFTK01Z and lot numbers 983:241 on the procedure tray.
The recall indicates ethylene oxide/ethylene chlorohydrin residues may cause tissue damage with prolonged contact, but the risk level is low for most users.
The recall does not specify a remedy, so check the device details to see if it matches the affected model and lot numbers.
Check for the catalog number BFTK01Z and lot numbers 983241 on the tray, or the unique device identifier (UDI-DI) 00191072214614.
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-2279-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2279-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
