Class II
Medical Device Recall: American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
American Contract Systems, Inc. · May 6, 2024
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
Distribution
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
States Affected
NATIONWIDE
Quantity Affected
15 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2521-2024
Status: ongoing
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