Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The MAYFIELD¿ Ultra 360 Base Unit for head positioner Recalled by Integra LifeSciences Corporation Due to Through an investigation of complaints, Integra found that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corporation directly.
Affected Products
The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.
Quantity: 1053 Units
Why Was This Recalled?
Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Integra LifeSciences Corporation
Integra LifeSciences Corporation has 29 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report