Recall Z-0954-2013— Ebi, Llc
Class II · Terminated
Class II FDA medical device recall by Ebi, Llc, initiated 2013-02-07, terminated 2015-12-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.. Reason: Increased risk of failure at the driver tip during screw insertion or removal..
- Recalling firm
- Ebi, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-07
- Terminated
- 2015-12-07
- Firm location
- Parsippany, NJ, United States
Product description
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
Reason for recall
Increased risk of failure at the driver tip during screw insertion or removal.
Data sourced from openFDA. This site is unofficial and independent of the FDA.