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Recall Observatory FDA recall evidence

Device product

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.

Z-0455-2014

September 30, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 66538
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0455-2014

Official wording

Reason: 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.

Code information: part no. 04.647.117S, Plate implant no. 7706771, spacer lot no. 7675745

Distribution pattern: Nationwide Distribution - only AZ .

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.