Brainlab AG: Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Is my product affected?

Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

• UPC 04056481002626

Check against the official notice below — it lists the full affected range.

What happened

Brainlab AG has recalled Femoral and Tibial Cutting Block Adapter Base components of its Knee Navigation System due to certain units with specific serial numbers potentially containing parts made from incorrect material, rendering them unsuitable for reprocessing. The recalled products include Model/Catalog Numbers 41888-04, 41866-77A, and 99700-43, with serial numbers ranging from 1267114001 to 1267114070 and 1308615001 to 1308615045. A total of 29 units were distributed to consignees in the United States (New York, Wisconsin, Oklahoma, and the District of Columbia) and internationally to Australia, Belarus, Germany, India, Japan, Malaysia, Singapore, Switzerland, the United Arab Emirates, and the United Kingdom.

The source document does not specify what remedy consumers should pursue.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: 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 Distribution: 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. Quantity: 29 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU2016-10-25
• Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit2016-10-25
• SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths 2016-10-25
• 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-0012016-10-21
• Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.2016-11-07

All FDA (Device enforcement) recalls