FDA Medical Device Recalls (openFDA)
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 number
- Z-0115-2008
- Recalling firm
- Biomet, Inc.
- 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
- Status
- Terminated
- Initiated
- 2007-09-04
- Posted
- 2008-01-23
- Terminated
- 2009-09-22
- Reason
- 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.
- Root cause
- Other
- 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.
- Quantity
- 22
- Distribution
- Nationwide; including states of Alabama, Arizona, Arkansas, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Nevada, North Carolina, Ohio and South Dakota.
- Lot, serial or model codes
- Lots 095112 and 474660.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28