Device 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
Z-2318-2017
Product summary
- Event
- Event 77251
- Status
- Terminated
- Classification
- Class II
- Quantity
- 497 units
- Official record key
device-enforcement:Z-2318-2017
Official wording
Reason: 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.
Code information: Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)
Distribution pattern: Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
Derived failure modes
-
Potency or specification failure
out of specification