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Terminated

Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN.

FDA Recall Z-0705-2008 · Posted 2008-02-05

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2007-10-18
Date Terminated2008-03-11
Product Quantity141 total for all recalls Z-0700-0705-2008

Reason for Recall

The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component.

Firm Action

Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.

Root Cause

Process control

Distribution Pattern

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Official Source

View FDA Recall →

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

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