Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes… — Class II medical device recall Z-0455-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-11, distributed nationwide. A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the bloc
| Recall number | Z-0455-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2013-09-30 |
| Classified | 2013-12-05 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2015-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| Lot numbers | 7675745 |
| Model numbers | 04.647.117S |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0455-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.