Medical device recalls Moderate risk

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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