Recall Z-2318-2017
Zimmer Biomet Spine Inc. · initiated May 10, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)
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.
FDA-determined cause: Device Design
Action taken
Consignees will be notified on 5/15/17 via certified mail to return products.
Details
- Recall number
- Z-2318-2017
- Initiated
- May 10, 2017
- Posted by FDA
- May 15, 2017
- Terminated
- May 25, 2018
- Product code
- LYQ – Accessories, Fixation, Spinal Intervertebral Body
- Quantity
- 497 units
- Distribution
- Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
- Recalling firm
- Zimmer Biomet Spine Inc., Westminster, CO