American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenie...
FDA Recall #Z-2521-2024 — Class II — May 6, 2024
Product Description
American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
Reason for Recall
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
Recalling Firm
American Contract Systems, Inc. — Kansas City, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
15 kits
Distribution
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated