FDA-Device2021-10-13Class II

ARCH Leg Positioning System

Innovative Orthopedic Technologies, LLC
Hazard

Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.

Sold states
U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.
Affected count
10 units
Manufactured in
1115 Highway 124, Winnie, TX, United States
Products
ARCH Leg Positioning System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2022

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