FDA Device

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)

Hazard

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.

What You Should Do

Remedy

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.

Products

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, Regen
Brand
Biomet, Inc.
UPC
Lots 824920, 559080, 509420, 493210, 221060, 167220 and 129030.  .

Units Affected

94