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
This recall has been terminated (originally issued May 15, 2017).
- Company
- Zimmer Biomet Spine Inc.
- Recall Initiated
- May 10, 2017
- Posted
- May 15, 2017
- Terminated
- May 25, 2018
- Recall Number
- Z-2318-2017
- Quantity
- 497 units
- Firm Location
- Westminster, CO
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
Lot / Code Info
Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)
Root Cause
Device Design
Action Taken
Consignees will be notified on 5/15/17 via certified mail to return products.
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