Z-0455-2014Class II

Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel...

Name: Z-0455-2014 Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel...
Creator: Synthes USA HQ, Inc.
Published: 2013-09-30
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-09-30 / Terminated / root cause: manufacturing process

FDA source

Synthes USA HQ, Inc. began a recall of 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... on 2013-09-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0455-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-30
Posted: 2013-12-05
Terminated: 2015-04-16
Recalling firm: Synthes GmbH
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.
Product code: OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Synthes sent an email message dated March 23, 2012, to the sales representative who received the affected product. The email identified the product, the problem, and the action to be taken. The letter requested the sales rep examine inventory, stop using the product, and quarantine the affected product to ensure that it will not be used. Synthes instructed the customer not to remove any product from their account or return any product without further instruction. For questions they were instructed to call 610-719-5364. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 1
Distribution: Nationwide Distribution - only AZ .
Product codes and lots: part no. 04.647.117S, Plate implant no. 7706771, spacer lot no. 7675745

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0455-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0455-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-05

Product code OVE

K112068Class IISynthes Zero-P Variable Angle (Va)Synthes Spine Co.Lp / cleared 2011-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)