Recall Z-0072-2022— Innovative Orthopedic Technologies, LLC
Class II · Terminated
Class II FDA medical device recall by Innovative Orthopedic Technologies, LLC, initiated 2021-09-13, terminated 2024-01-29. FDA's recall record names no specific 510(k) clearance for this event. Product: ARCH Leg Positioning System. Reason: Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load..
- Recalling firm
- Innovative Orthopedic Technologies, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-09-13
- Terminated
- 2024-01-29
- Firm location
- Winnie, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.