Recall Z-0919-2013— Stryker Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2012-12-20, terminated 2015-09-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100. Reason: Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use..
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-20
- Terminated
- 2015-09-30
- Firm location
- Mahwah, NJ, United States
Product description
Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
Reason for recall
Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.