Recall Z-2594-2018— Integra LifeSciences Corp.
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2018-06-29, terminated 2020-02-26. FDA's recall record names no specific 510(k) clearance for this event. Product: MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A 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.. Reason: There is a potential for the knob assembly in the swivel adapter to fracture/break during use..
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-29
- Terminated
- 2020-02-26
- Firm location
- Plainsboro, NJ, United States
Product description
MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A 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.
Reason for recall
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.