FDADecember 19, 2014device
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 exa...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
integra lifesciencesintegra
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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