Z-0072-2022 Class II Terminated
FDA device recall Z-0072-2022 was initiated by Innovative Orthopedic Technologies, LLC on September 13, 2021 and is designated Class II. Reason for recall: Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load. The recall status is terminated (terminated January 29, 2024). Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 13, 2021
- Initiation Date
- September 13, 2021
- Termination Date
- January 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
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 Pattern
U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.
Code Information
Model: 6813010 Serial Numbers: 6813010.0066; 6813010.0067; 6813010.0069; 6813010.0070; 6813010.0071; 6813010.0072; 6813010.0073; 6813010.0074; 6813010.0075; 6813010.0076;