Class 2 Device Recall Vitality Spinal Fixation System

• Date Initiated by Firm: May 10, 2017
• Date Posted: May 15, 2017
• Recall Status: Terminated 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)
• FEI Number: 3012447612
• 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: 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.