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Terminated

Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581

FDA Recall Z-0102-2008 · Posted 2007-10-27

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2007-08-09
Date Terminated2009-06-26
Product Quantity5

Reason for Recall

Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended.

Firm Action

The distributor was notified via phone on or about 8/9/07 and by letter dated 8/31/07 and requested to return the product. Returns included subaccounts

Root Cause

Process control

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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