Z-1151-2007

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

Name: Z-1151-2007 Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF...
Creator: Biomet, Inc.
Published: 2007-06-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2007-06-14 / 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 2007-06-14. The reason FDA records is "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". 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-1151-2007
Status: Terminated
Initiated: 2007-06-14
Posted: 2007-08-07
Terminated: 2007-12-12
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)
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Other
Action: 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.
Quantity in commerce: 94
Distribution: World wide: USA, Australia, and Finland.
Product codes and lots: Lots 824920, 559080, 509420, 493210, 221060, 167220 and 129030. .

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)