FDAJune 29, 2018device

MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

What to do

FDA enforcement status: Terminated

Brands named

integra lifesciencesintegra

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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