Device product
Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
Z-0919-2013
Product summary
- Event
- Event 64306
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 units
- Official record key
device-enforcement:Z-0919-2013
Official wording
Reason: Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
Code information: Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.