Biomet, Inc. 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) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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)
Brand
Biomet, Inc.
Lot Codes / Batch Numbers
Lots 824920, 559080, 509420, 493210, 221060, 167220 and 129030. .
Products Sold
Lots 824920, 559080, 509420, 493210, 221060, 167220 and 129030. .
Biomet, Inc. is recalling Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component inser due to The instrument was manufactured incorrectly and use could result in the instrument binding to the acetabular component and cause implant to not relea. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026