American Contract Systems recalls ORIF hip implant procedure kits with catalog number UTHP44S due to excessive ethylene oxide/ethylene chlorohydrin residuals, potentially causing tissue damage with long-term 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 hip implant procedure kits (catalog number UTHP44S) because residual chemicals from the manufacturing process may cause tissue damage over time. This recall affects medical professionals using these kits for hip surgeries.
The hip implant procedure kits contain ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for long-term exposure. These chemicals can cause tissue damage if the implants remain in the body for extended periods after surgery.
Medical professionals who use the recalled hip implant procedure kits for surgeries are most at risk. Patients receiving these implants may also be affected if the kits were used in their procedures.
Check for the catalog number UTHP44S on the kit packaging. The lot numbers 639231 and 936241 are also associated with this recall.
Verify the catalog number and lot numbers on the kit packaging to confirm if it is recalled.
The recall is due to ethylene oxide and ethylene chlorohy: residues exceeding safe levels for long-term exposure, which could cause tissue damage.
Look for the catalog number UTHP44S and lot numbers 639231 or 936241 on the kit packaging.
The recall does not specify a remedy, so check with the manufacturer 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-2309-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2309-2024 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.
