Synthes Zero-P VA Implant Recalled for Potential Screw Back-Out Risk
Synthes USA is recalling specific Zero-P VA implants because a screw could back out if the blocking mechanism is not visually confirmed to cover the screw head.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical failure (screw back-out) in a spinal implant, which poses a risk of harm, but the source text does not report any specific injuries or hospitalizations, placing it in the High severity category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synthes USA HQ, Inc. is recalling the Synthes Zero-P VA Implant 7 MM Height Parallel Sterile. This is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease at one level from C2-T1.
The recall was initiated because a potential non-conformance was identified where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw. The affected units are identified by part no. 04.647.117S, plate implant no. 7706771, and spacer lot no. 7675745.
The recall is classified as Class II by the FDA. The distribution pattern is listed as nationwide distribution, with specific mention of Arizona. Healthcare providers and patients should contact Synthes USA HQ, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- 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…
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- part no. 04.647.117S
- Plate implant no. 7706771
- spacer lot no. 7675745
Distribution
Distributed nationwide across the United States.
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