FDA-Device2012-12-26Class II

Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178

Ebi, Llc
Hazard

Broken screw insertor hardness was measured and found to be below the acceptable limits.

Sold states
Nationwide Distribution, including the states of MO, TX, and IN.
Affected count
15 units
Manufactured in
100 Interpace Pkwy, Parsippany, NJ, United States
Products
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0536-2013

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