—#122562

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.

FDA product code: OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K112068
Affected lot / code info: part no. 04.647.117S, Plate implant no. 7706771, spacer lot no. 7675745

Why it was recalled

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 (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Nationwide Distribution - only AZ .

Timeline

Recall initiated: 2013-09-30
Posted by FDA: 2013-12-05
Terminated: 2015-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122562. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.