Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0455-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 30, 2013

Date Posted: December 11, 2013

Recall Number: Z-0455-2014

Event ID: 66538

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.

Status: Terminated

Product Quantity: 1

Code Information:

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

Distribution Pattern:

Nationwide Distribution - only AZ .

Voluntary or Mandated:

Voluntary: Firm initiated