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U.S. Department of Health and Human Services

Class 2 Device Recall Vitality Spinal Fixation System

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  Class 2 Device Recall Vitality Spinal Fixation System see related information
Date Initiated by Firm May 10, 2017
Date Posted May 15, 2017
Recall Status1 Terminated 3 on May 25, 2018
Recall Number Z-2318-2017
Recall Event ID 77251
Product Classification Accessories, fixation, spinal intervertebral body - Product Code LYQ
Product Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
Code Information Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)
Recalling Firm/
Manufacturer		 Zimmer Biomet Spine Inc.
10225 Westmoor Dr
Westminster CO 80021-2702
For Additional Information Contact Ms. Ashley McPherson
303-465-8929
Manufacturer Reason
for Recall		 Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs because when applying torque to tighten the closure top the driver has the potential to create a torsional spring which can cause damage and the potential for the values of torque to go out of specification.
FDA Determined
Cause 2		 Device Design
Action Consignees will be notified on 5/15/17 via certified mail to return products.
Quantity in Commerce 497 units
Distribution Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
Total Product Life Cycle TPLC Device Report
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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