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Recall Observatory FDA recall evidence

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

May 10, 2017

Class II

Product summary

Firm
Zimmer Biomet Spine Inc.
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

    reason.potency_specification_failure · v1.0.0

    out of specification