Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
FDA device recall Z-0919-2013 · posted 2013-03-08 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
- Action taken
- 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
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 48 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-12-20
- Date posted
- 2013-03-08
- Date terminated
- 2015-09-30
- Location
- Mahwah, NJ
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