PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 18, 2017 Initiated: October 27, 2016 #Z-0959-2017

Product Description

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

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

Details

Recalling Firm
Brainlab AG
Units Affected
29 units
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.
Location
Munich

Frequently Asked Questions

What product was recalled?
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic. Recalled by Brainlab AG. Units affected: 29 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-0959-2017.