FDA recall Z-0072-2022
Innovative Orthopedic Technologies, LLC · Class II · device
Product
ARCH Leg Positioning System
Reason for recall
Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
Distribution
U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.
Key facts
- Status
- Terminated
- Initiation date
- 2021-09-13
- Report date
- 2021-10-13
- Termination date
- 2024-01-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Winnie, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2022