Integra LifeSciences Corp.: Medical Device Recall in 2018 - (Recall #: Z-2594-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 29, 2018

Date Posted: August 8, 2018

Recall Number: Z-2594-2018

Event ID: 80421

Reason for Recall:

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

Status: Terminated

Product Quantity: 1 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated