American Contract Systems recalls TOTAL KNEE-Procedure Kit (SMTK21C) due to potential ethylene oxide residuals exceeding safety limits. This could cause injury during long-term use. Affected units include specific catalog numbers and 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 KNE:Procedure Kit (SMTK21C) because ethylene oxide residues in the cast padding may cause injury with prolonged use. This is a medical device that could pose a risk to patients during healing.
Ethylene oxide and ethylene chlorohydrin residues in the cast padding could cause injury if the device is used for extended periods. The safety standards (ANSI/AAMI/ISO 10993-7) indicate these residues exceed acceptable levels for permanent exposure devices.
Healthcare professionals using this medical device for knee procedures are most at risk. Patients receiving the kit for knee treatments may be affected if the device is used improperly.
Check for catalog number SMTK21C on the kit. Affected units include specific lot numbers: 975241, 956241, 920241, 907241. The UDI-DI code 00191072203205 is also associated with these units.
Verify the catalog number and lot numbers listed in the recall notice to confirm if your kit is affected.
The recall indicates ethylene oxide residues may exceed safety limits, so it is not safe for long-term use. Affected units should be checked and disposed of if applicable.
The recall does not specify a remedy, so contact American Contract Systems directly for guidance on next steps.
Check for catalog number SMTK21C and lot numbers 975241, 956241, 920241, or 907241. The UDI-DI code 00191072203205 is also associated with these units.
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-2302-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2302-2024 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.
