Recall Z-0455-2014 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Synthes USA HQ, Inc.
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.
| Date | Dec 5, 2013 (initiated Sep 30, 2013) |
| Status | Terminated |
| Reason | 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 | 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 | 1 |
| Distribution | Nationwide Distribution - only AZ . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112068 | SYNTHES ZERO-P VARIABLE ANGLE (VA) Synthes Spine Co.Lp, Nov 7, 2011 |