Innovative Orthopedic Technologies, LLC recalls ARCH Leg Positioning System
- Recall date
- September 13, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0072-2022
- FDA classification
- Class II
- Brand / firm
- Innovative Orthopedic Technologies, LLC
- Sold / distributed
- U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.
Why it was recalled
Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ARCH Leg Positioning System
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