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Terminated

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

FDA Recall Z-0919-2013 · Posted 2013-03-08

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2012-12-20
Date Terminated2015-09-30
Product Quantity48 units

Reason for Recall

Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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