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)
FDA Recall Z-1151-2007 · Posted 2007-08-07
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2007-06-14
Date Terminated2007-12-12
Product Quantity94
Reason for Recall
The instrument was manufactured incorrectly and use could result in the instrument binding to the acetabular component and cause implant to not release following inpaction.
Firm Action
On 6/13/07, the firm sent a Urgent Medica Device Correction Notice to its sales force instructing them to retrieve affected units from their hospital accounts and to return them to the firm. International accounts were notified via email on 6/14/07.
Root Cause
Other
Distribution Pattern
World wide: USA, Australia, and Finland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.