FDA-Device2013-11-27Class II
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
Ebi, Llc
Hazard
Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.
Sold states
Nationwide distribution including Puerto Rico.
Affected count
7,092 units
Manufactured in
100 Interpace Pkwy, Parsippany, NJ, United States
Products
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0359-2014Don't want to check this manually?
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