American Contract Systems recalls TOTAL KNEE-Procedure Kit (SFTK54B) 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 Kit (SFT:K54B) because ethylene oxide and ethylene chlorohydrin residues in the cast padding may cause tissue damage with long-term use. This affects medical professionals using the kit for knee procedures.
Ethylene oxide and ethylene chlorohydrin residues in the cast padding may cause tissue damage if the kit is used for extended periods. The hazard is related to residual chemical exposure during medical procedures.
Medical professionals who use the TOTAL KNEE-Procedure Kit for knee surgeries are most at risk. The recall applies to kits with specific catalog numbers and lot numbers.
Check for catalog number SFTK54B on the kit. Affected kits have specific lot numbers: 680231, 997241, 969241, 947241.
Verify the catalog number and lot numbers listed in the recall notice to confirm if your kit is affected.
The recall indicates potential tissue damage from prolonged exposure to ethylene oxide and ethylene chlorohydrin residues, but the risk is considered low for typical use.
Check for catalog number SFTK54B and lot numbers 680231, 997241, 969241, or 947241 on the kit.
The recall does not specify a remedy, so contact American Contract Systems for guidance on next steps.
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-2299-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2299-2024 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.
