Reported Jun 14, 2017 · Terminated
Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model…
Zimmer Biomet Spine Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet Spine Inc. · 10225 Westmoor Dr · Westminster, CO · 80021-2702
Is this the product you have?
- Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90
- in-lbs Model Number(s)
07.02066.00107.02053.001730M0017
- Lot codes and dates
- Model No07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)
- Amount recalled
- 497 units
Where it was sold
- Nationwide
- VA
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.
This product could cause temporary or reversible health problems — stop using it.
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