Recall Z-2318-2017— Zimmer Biomet Spine Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet Spine Inc., initiated 2017-05-10, terminated 2018-05-25. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Zimmer Biomet Spine Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-10
- Terminated
- 2018-05-25
- Firm location
- Westminster, CO, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.