FDAClass IIJune 14, 2017

Vitality Spinal Fixation System recall

Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001…

Why was Vitality Spinal Fixation System 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)

Product
Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001…
Recalling firm
Zimmer Biomet Spine Inc.
Quantity
497 units
Distribution
Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
Recall date
June 14, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls