FDAFDA · Food and drugs·Recall number Z-0455-2014
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.
Published December 11, 2013 · Recall initiated: September 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Nationwide Distribution - only AZ .
- Lot
- part no. 04.647.117S, Plate implant no. 7706771, spacer lot no. 7675745
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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