Z-0455-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2013
- Initiation Date
- September 30, 2013
- Termination Date
- April 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1.
Reason for Recall
A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw.
Distribution Pattern
Nationwide Distribution - only AZ .
Code Information
part no. 04.647.117S, Plate implant no. 7706771, spacer lot no. 7675745