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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes ZeroP VA Implant 7 MM Height Parallel Sterile

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 Class 2 Recall
Synthes ZeroP VA Implant 7 MM Height Parallel Sterile
see related information
Date Posted December 05, 2013
Recall Status1 Open
Recall Number Z-0455-2014
Recall Event ID 66538
Premarket Notification
510(K) Number
K112068 
Product Classification Intervertebral Fusion Device With Integrated Fixation, Cervical - Product Code OVE
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.
Code Information part no. 04.647.117S, Plate implant no. 7706771, spacer lot no. 7675745
Recalling Firm/
Manufacturer
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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 .
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OVE and Original Applicant = SYNTHES SPINE CO.LP
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