medical Class II Updated 2018-08-08

Integra LifeSciences Corp. recalls MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E

Recalled Product

MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E 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 freedom is required and where X-ray imaging modalities will be used.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 69626; 78445; 81360; 1526205; 1560439; 1610839; 1527910; 1560448; 1621857; 1959100; 2012964
View official government recall

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