Brainlab AG recalls Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereo…

Recall date

October 27, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0959-2017

FDA classification

Class II

Brand / firm

Brainlab AG

Sold / distributed

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.

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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