Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MAYFIELD¿ Composite Series Base Unit Standard Recalled by Integra LifeSciences Corp. Due to Integra determined there is a possibility that the...

Date: December 21, 2012
Company: Integra LifeSciences Corp.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.

Affected Products

MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD¿ Base Units are 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.

Quantity: 96 units

Why Was This Recalled?

Integra determined there is a possibility that the Base Units may break during use.

Where Was This Sold?

This product was distributed to 32 states: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KY, MD, MA, MI, MN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI

Affected (32 states)Not affected

About Integra LifeSciences Corp.

Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report