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), Biomet Orthopedics, Inc., Warsaw, IN. 46581 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), Biomet Orthopedics, Inc., Warsaw, IN. 46581
Brand
Biomet, Inc.
Lot Codes / Batch Numbers
Lots 095112 and 474660.
Products Sold
Lots 095112 and 474660.
Biomet, Inc. is recalling Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component inser due to Binding: The instrument was manufactured incorrectly and its use may result in binding to the acetabular component and cause the implant to not releas. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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