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.
What this means for you
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.
Related recalls
Same manufacturer · Zimmer Biomet Spine Inc.
See all →- HighSpinal fixation screws recalled due to incorrect size laser marking
FDA (Devices) · 2024-01-10
- HighZimmer Biomet Recalls Vitality Spinal Fixation Set Screws
FDA (Devices) · 2019-03-06
- HighZimmer Biomet Recalls Vitality Spinal Fixation Set Screws
FDA (Devices) · 2019-03-06
- HighZimmer Biomet Recalls Vitality Spinal Fixation Set Screws
FDA (Devices) · 2019-03-06
- HighZimmer Biomet Recalls Altius M-INI OCT Spinal Fixation System
FDA (Devices) · 2017-04-05
Same hazard · device damage
See all →- HighRENASYS EDGE 800ML Canister Recalled for Carbon Filter Damage Risk
FDA (Devices) · 2024-04-24
- SevereNimbus II Infusion Pump Systems Recalled for Multiple Potential Device Failures
FDA (Devices) · 2024-04-03
- HighBaxter peritoneal dialysis transfer sets may crack or leak with certain cleaners
FDA (Devices) · 2022-02-16
- HighCorin Unity Knee Augments Recalled Due to Packaging Damage and Sterility Loss
FDA (Devices) · 2021-10-06
- ModerateNovo Nordisk Recalls Saxenda Injection Samples Due to Temperature Abuse
FDA (Drugs) · 2021-04-21