Z-0115-2008

Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF...

Name: Z-0115-2008 Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF...
Creator: Biomet, Inc.
Published: 2007-09-04
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2007-09-04 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected... on 2007-09-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0115-2008
Status: Terminated
Initiated: 2007-09-04
Posted: 2008-01-23
Terminated: 2009-09-22
Recalling firm: Zimmer GmbH
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
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 22
Distribution: Nationwide; including states of Alabama, Arizona, Arkansas, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Nevada, North Carolina, Ohio and South Dakota.
Product codes and lots: Lots 095112 and 474660.

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)