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Ebi, Llc recalls BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for im
Recalled November 27, 2013 · FDA recall Z-0359-2014 · Ebi
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. · FDA Class II
Units
7,092 units
Sold at
Nationwide distribution including Puerto Rico.
Description
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.
Product
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
Manufacturer(s)
Ebi, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →