Device product
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Z-0959-2017
Product summary
- Firm
- Brainlab AG
- Event
- Event 75548
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 units
- Official record key
device-enforcement:Z-0959-2017
Official wording
Reason: Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing
Code information: Model/Catalog Number: 41888-04 Description: FEM&TIB CUT BLOCK ADP "UNIVERSAL" BASE1 Model/Catalog Number:41866-77A Description: FEM&TIB CUT BLOCK ADAPTER KIT UNIV Model/Catalog Number: 99700-43 Description: IGS INSTRUMENTATION UDI: GTIN 04056481002626 Serial numbers/lot numbers: - 1267114001 1267114070 - 1308615001 1308615045
Distribution pattern: US Consignees located in the following states: New York, Wisconsin, Oklahoma and District of Columbia.***Foreign Conisgnees located in the following countries: Australia; Belarus; Germany; India; Japan; Malaysia; Singapore; Switzerland; United Arab Emirates and United Kingdom.
Derived failure modes
-
Unknown
Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing