medical Class II Updated 2018-08-08

Integra LifeSciences Corp. recalls MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The M

Recalled Product

MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 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: 57218; 58242; 59524; 61083; 61084; 61533; 61559; 62801; 63826; 63949; 65966; 65967; 66950; 67912; 70432; 70564; 74838; 76382; 78005; 79436; 79475; 81218; 84107; 86162; 88507; 89760; 1468037; 1558488; 1664697; 1755770; 1485531; 1726814; 1737849; 1795116; 1939414; 2051032; 2135345; 2162789; 2247499; 2353536; 2380794; 2450908; 2463223; 2497401; 2517644; 2556854; 2642914; 2642922; 2740222; 2760809; 2760810; 2781235; 2781238
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