Recall Z-1084-2015— Integra LifeSciences Corporation
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corporation, initiated 2014-12-19, terminated 2017-02-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Integra LifeSciences Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-19
- Terminated
- 2017-02-22
- Firm location
- Cincinnati, OH, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.