Date Initiated by Firm | September 30, 2013 |
Date Posted | December 05, 2013 |
Recall Status1 |
Terminated 3 on April 16, 2015 |
Recall Number | Z-0455-2014 |
Recall Event ID |
66538 |
510(K)Number | K112068 |
Product Classification |
Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
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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 PA 19380-3417
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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 | 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
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = OVE
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