FDA-Device2013-12-11Class II
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.
Synthes USA HQ, Inc.
Hazard
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.
Sold states
Nationwide Distribution - only AZ .
Affected count
1
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0455-2014Don't want to check this manually?
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