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Recall Observatory FDA recall evidence

Device product

American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit

Z-2521-2024

May 06, 2024

Class II

Product summary

Firm
American Contract Systems, Inc.
Event
Event 94908
Status
Ongoing
Classification
Class II
Quantity
15 kits
Official record key
device-enforcement:Z-2521-2024

Official wording

Reason: 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

Code information: (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.

Distribution pattern: US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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