FDA-Device2013-03-27Class II
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.
Ebi, Llc
Hazard
Increased risk of failure at the driver tip during screw insertion or removal.
Sold states
Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
Affected count
59 units.
Manufactured in
100 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0954-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief