Z-1353-2009

Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. For use in primary hip arthroplasty

Name: Z-1353-2009 Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. For use in primary hip arthroplasty
Creator: Biomet, Inc.
Published: 2009-03-31
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-03-31 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. For use in primary hip arthroplasty on 2009-03-31. The reason FDA records is "The handle body may fracture or crack at the slot where the locking lever is inserted to clamp down onto the broach". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1353-2009
Status: Terminated
Initiated: 2009-03-31
Posted: 2009-06-01
Terminated: 2009-12-23
Recalling firm: Zimmer GmbH
Product: Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. For use in primary hip arthroplasty.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The handle body may fracture or crack at the slot where the locking lever is inserted to clamp down onto the broach.
Root cause tag: design
FDA root cause: Device Design
Action: Biomet notified their distributors by recall letter dated 3/31/09, instructed them to pick up the insturments at the hospitals and to notify the hospital personnel of this recall action in writing.
Quantity in commerce: 178 of all products.
Distribution: Nationwide, Canada and Finland.
Product codes and lots: Lots 069990, 141040, 147360, 316160, 401900, 401910, 417580, 523120, 605420, 829970, 873000, 901610 and 930110.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)