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.

Class I - Dangerous

🏥 Medical Devices Recalled: June 29, 2018 Integra LifeSciences Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
69626; 78445; 81360; 1526205; 1560439; 1610839; 1527910; 1560448; 1621857; 1959100; 2012964
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Integra LifeSciences Corp.
Reason for Recall:: There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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.