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Terminated

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

FDA Recall Z-2318-2017 · Posted 2017-05-15

Recalling FirmZimmer Biomet Spine Inc.
Recall StatusTerminated
Product CodeLYQ
Date Initiated2017-05-10
Date Terminated2018-05-25
Product Quantity497 units

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.

Firm Action

Consignees will be notified on 5/15/17 via certified mail to return products.

Root Cause

Device Design

Distribution Pattern

Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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