Extremity Convenience Kit (American Contract Systems) – Sterilization Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
Brand
American Contract Systems, Inc.
Lot Codes / Batch Numbers
(1) Model No ALEX17A, UDI-DI 00191072201546, Lot 983241, Exp. Date 1/17/2025, (2) Model No AKHD97A, UDI-DI 00191072201126, Lot 988241, Exp. Date 1/12/2025, (3) Model No CETJ13O, UDI-DI 00191072202017, Lot 989241, Exp. Date 1/11/2025.
Products Sold
(1) Model No ALEX17A; UDI-DI 00191072201546, Lot 983241;Exp. Date 1/17/2025; (2) Model No AKHD97A; UDI-DI 00191072201126; Lot 988241;Exp. Date 1/12/2025; (3) Model No CETJ13O; UDI-DI 00191072202017; Lot 989241;Exp. Date 1/11/2025.
American Contract Systems, Inc. is recalling American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience due to Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Recommended Action
Per FDA guidance
The recalling firm issued recall letters on and dated 5/6/2024 via email or overnight mail. The letter explained the event details, product involved, risk to health, and actions to take. The actions included (1) review your inventory and segregate and quarantine all affected trays. If any of the trays have been further distributed, ensure all end users are notified and maintain records of effectiveness; (2) discard all affected kits and document on the enclosed Response Form; and (3) complete the enclosed Response Form and return it as soon as possible.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026