Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s
FDA device recall Z-2318-2017 · posted 2017-05-15 · Terminated
Recall details
- Recalling firm
- Zimmer Biomet Spine Inc.
- Reason for recall
- 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.
- Action taken
- Consignees will be notified on 5/15/17 via certified mail to return products.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LYQ
- Quantity affected
- 497 units
- Distribution
- Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
- Date initiated
- 2017-05-10
- Date posted
- 2017-05-15
- Date terminated
- 2018-05-25
- Location
- Westminster, CO
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