Biomet RINGLOC + Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623, Biomet Orthopedics, Inc., Warsaw, IN.
FDA Recall Z-0703-2008 · 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.