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Terminated

Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38), Biomet Orthopedics, Inc., Warsaw, IN. 46581

FDA Recall Z-0115-2008 · Posted 2008-01-23

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2007-09-04
Date Terminated2009-09-22
Product Quantity22

Reason for Recall

Binding: The instrument was manufactured incorrectly and its use may result in binding to the acetabular component and cause the implant to not release following impaction.

Firm Action

Consignees were notified by Urgent Medical Device Correction Notice (letter) dated 9/4/07 to discontinue use of the instruments and to return them for evaluation.

Root Cause

Other

Distribution Pattern

Nationwide; including states of Alabama, Arizona, Arkansas, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Nevada, North Carolina, Ohio and South Dakota.

Official Source

View FDA Recall →

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

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