Z-0455-2014 Class II Terminated
FDA device recall Z-0455-2014 was initiated by Synthes USA HQ, Inc. on Sep 30, 2013 and is designated Class II. 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. The recall status is terminated (terminated Apr 16, 2015). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 11, 2013
- Initiation Date
- Sep 30, 2013
- Termination Date
- Apr 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