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Terminated

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

FDA Recall Z-0536-2013 · Posted 2012-12-17

Recalling FirmEbi, Llc
Recall StatusTerminated
Product CodeHXX
Date Initiated2012-09-29
Date Terminated2015-12-07
Product Quantity15 units

Reason for Recall

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

Firm Action

Biomet mailed Urgent Medical Device Recall Notice/Fax Back Response Form dated 9/25/2012 to the distributors on 9/29/2012.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution, including the states of MO, TX, and IN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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