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.
Reported: March 27, 2013 Initiated: February 7, 2013 #Z-0954-2013
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.
Details
- Recalling Firm
- Ebi, Llc
- Units Affected
- 59 units.
- Distribution
- Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ebi, Llc. Units affected: 59 units..
Why was this product recalled? ▼
Increased risk of failure at the driver tip during screw insertion or removal.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2013. Severity: Moderate. Recall number: Z-0954-2013.
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