American Contract Systems recalls TOTAL KNEE Procedure Tray (Catalog ANTK12AF) due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, potentially causing tissue damage 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 Tray (Catalog ANTK12AF) because ethylene oxide and ethylene chlorohydrin residues in the cast padding may cause tissue damage with long-term use. This affects medical devices used in orthopedic procedures.
The cast padding component contains ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for long-term use. These chemicals can cause tissue damage if the device remains in contact with the body for extended periods.
Healthcare professionals using the TOTAL KNEE Procedure Tray for orthopedic procedures are most at risk. Patients receiving the device for cast padding may also be affected.
Check for the catalog number ANTK12AF on the procedure tray. The device was sold with lot numbers starting with 968241. The UDI-DI code 00191072214553 identifies the specific batch.
Identify the catalog number (ANKT12AF) and lot numbers starting with 968241 on the procedure tray.
The recall indicates the device may have unsafe chemical residues that could cause tissue damage with prolonged use, so it should not be used without checking the recall status.
The recall record does not specify a remedy, so contact American Contract Systems for guidance on next steps.
Look for the catalog number ANTK12AF and lot numbers starting with 968241 on the procedure 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-2275-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2275-2024 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.
