medical Class II Updated 2018-08-08

Integra LifeSciences Corp. recalls MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R

Recalled Product

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 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: 56487; 57300; 57825; 58248; 59022; 59844; 61783; 61850; 62702; 63701; 64835; 66039; 66914; 68778; 81912; 85485; 86195; 88511; 1501445; 1664646; 1584488; 1713505; 1959097; 2076251; 2337182; 2450911; 2556851; 2664422; 2798806; 2798981; 2647413; 2781302
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