# FDA recall Z-2592-2018

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2018-06-29.

## Product

MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079     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.

## Distribution

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.

## Key facts

- **Recall number:** Z-2592-2018
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-29
- **Report date:** 2018-08-08
- **Termination date:** 2020-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plainsboro, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2592-2018

## Citation

> AI Analytics. FDA recall Z-2592-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2592-2018. Source: US FDA. Licensed CC0.

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