Zimmer Biomet Recalls Vitality Spinal Fixation System Drivers
Zimmer Biomet is recalling Vitality T27 Final Drivers and Torque Limiting Handles because they may create torsional springs that damage the device or cause torque values to go out of specification.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Zimmer Biomet Spine Inc. is conducting a Class II recall for 497 units of the Vitality Spinal Fixation System, specifically the Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs. The affected model numbers are 07.02066.001, 07.02053.001, and 730M0017.
The recall is being issued because applying torque to tighten the closure top on the driver has the potential to create a torsional spring. This mechanism can cause damage to the device and result in torque values going out of specification.
The affected units were distributed nationwide to military, VA, government, and foreign consignees, with no Canadian consignees. Model 07.02053.001 is affected for all lots distributed prior to April 26, 2017, while Model 730M0017 is affected for Lot 309622. Model 07.02066.001 is affected for all lots.
The recalled product
- 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
- Manufacturer
- Zimmer Biomet Spine Inc.
- Category
- Medical Device — Spinal Fixation
- Affected units
- 497
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model No: 07.02066.001 (All lots)
- 07.02053.001 (All lots distributed prior to April 26
- 2017)
- and 730M0017 (Lot 309622)
Distribution
Distributed nationwide across the United States.
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