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Recall Observatory FDA recall evidence

Device 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.

Z-2594-2018

June 29, 2018

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 80421
Status
Terminated
Classification
Class II
Quantity
1 units
Official record key
device-enforcement:Z-2594-2018

Official wording

Reason: There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

Code information: CD-0436

Distribution pattern: Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV; and to countries of:: Australia, Canada, China, Dominican Republic, Hong Kong, India, Japan, Korea, Malaysia, Mexico, Pakistan, Panama, Peru, Singapore, Sri Lanka, Taiwan, and Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for the knob assembly in the swivel adapter to fracture/break during use.