Zimmer Biomet Spine Inc. recalls Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Numbe…

Recall date

May 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2318-2017

FDA classification

Class II

Brand / firm

Zimmer Biomet Spine Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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