American Contract Systems recalls CUSTOM KNEE 206061 Procedure Kit (UDKN68AE) 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 their CUSTOM KNEE 20606: 206061 Procedure Kit (UDKN68AE) because ethylene oxide/ethylene chlorohydrin residues in the cast padding exceed safety limits. This could cause tissue damage if the cast is worn for extended periods.
The cast padding in this kit contains ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for long-term use. These chemicals can cause tissue damage if the cast is worn for extended periods, especially in medical applications.
People who own or use the CUSTOM KNEE 206061 Procedure Kit (UDKN68AE) with lot numbers 651231 are affected. Those with medical casts made from this kit are at higher risk.
Check for the catalog number UDKN68AE and lot number 651231 on the kit. The product is sold under American Contract Systems Inc.
Verify the catalog number UDKN68AE and lot number 651231 on the CUSTOM KNEE 206061 Procedure Kit.
The recall is for potential tissue damage from excessive ethylene oxide/ethylene chlorohydrin residues in the cast padding, but the risk is low with proper use.
The official recall record does not specify a remedy or action steps for this product.
Look for the catalog number UDKN68AE and lot number 651231 on the CUSTOM KNEE 206061 Procedure Kit.
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-2307-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2307-2024 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.
