Date Initiated by Firm |
February 03, 2016 |
Create Date |
February 26, 2016 |
Recall Status1 |
Terminated 3 on October 11, 2016 |
Recall Number |
Z-1019-2016 |
Recall Event ID |
73265 |
510(K)Number |
K133556
|
Product Classification |
Appliance, fixation, spinal interlaminal - Product Code KWP
|
Product |
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3). |
Code Information |
Surgical Technique Manual L1637 Rev B (2014-06) |
Recalling Firm/ Manufacturer |
Zimmer Spine, Inc. 7375 Bush Lake Rd Minneapolis MN 55439-2027
|
For Additional Information Contact |
Customer Service 866-774-6368
|
Manufacturer Reason for Recall |
Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Distributors, Hospital Risk Managers and Surgeons were notified via an Urgent Medical Device Correction letter beginning 2/3/2016. The letter identified affected product, described the issue and listed their responsibilities. A Certificate of Acknowledgement form was asked to be returned to Zimmer Biomet via email to corporatequality.postmarket@zimmerbiomet.com.
Questions or concerns can be directed to Customer Service at 1-866-774-6368 |
Quantity in Commerce |
15,753 |
Distribution |
Distributed US (nationwide) and in the countries of Australia and Germany. |
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.
|
510(K) Database |
510(K)s with Product Code = KWP and Original Applicant = ZIMMER SPINE, INC.
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