Z-0919-2013Class II

Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100

Name: Z-0919-2013 Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
Creator: Stryker Howmedica Osteonics Corp.
Published: 2012-12-20
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-12-20 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100 on 2012-12-20. FDA classified it as Class II and gives the reason as "Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use". 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-0919-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-20
Posted: 2013-03-08
Terminated: 2015-09-30
Recalling firm: Howmedica Osteonics Corp
Product: Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (201) 972-2100 for questions regarding this issue.
Quantity in commerce: 48 units
Distribution: Nationwide Distribution.
Product codes and lots: Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0919-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0919-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-08

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)