Z-0533-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 9, 2022
- Initiation Date
- December 29, 2021
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 devices
Product Description
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Reason for Recall
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
Distribution Pattern
U.S.: CA, MI, NV, and TX O.U.S.: Portugal
Code Information
X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963