Recall Z-2318-2017 ยท LYQ Accessories, Fixation, Spinal Intervertebral Body
Zimmer Biomet Spine Inc.
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
| Date | May 15, 2017 (initiated May 10, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Consignees will be notified on 5/15/17 via certified mail to return products. |
| Quantity | 497 units |
| Distribution | Nationwide, military/VA/govt and foreign consignee (No Canadian consignees) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.