American Contract Systems recalls 30+ orthopedic surgical kits for potential loss of function or drug efficacy due to improper sterilization process.
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
American Contract Systems is recalling over 30 orthopedic surgical kits that may have been improperly sterilized, risking loss of function or reduced drug effectiveness. These kits are used for hip and knee surgeries and were sold with specific expiration dates.
During internal checks, ACS found that some components were added to their sterilization process without proper testing for heat exposure. This could cause parts to stop working or reduce medication effectiveness.
Orthopedic surgeons and medical facilities using the recalled kits for hip or knee procedures. Patients receiving these kits during surgery are not directly at risk.
Check for kit numbers listed in the recall (e.g., AHHF15C, BBHP10E) and expiration dates matching the specific lots provided. The kits are labeled for hip fracture, knee, or other orthopedic procedures.
Identify if your kit matches the listed numbers (e.g., AHHF15C, BBHP10E) and expiration dates in the recall notice.
The recall states that the kits may have reduced functionality or drug effectiveness, but they are not immediately dangerous. Affected users should check the kit numbers and expiration dates.
Look for kit numbers like AHHF15C or BBHP10E with specific expiration dates listed in the recall notice.
The recall does not require immediate discontinuation; users should check the kit numbers and expiration dates to determine if they are affected.
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-0833-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0833-2024 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.
