Agency classClass IIOur severity:High FDA (Devices)·Z-0869-2013·Announced 2013-02-27

Integra MAYFIELD Composite Base Units Recalled for Potential Breakage

Integra LifeSciences is recalling 96 MAYFIELD Composite Series Base Units because they may break during use, posing a risk to patients during surgical procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Integra LifeSciences Corporation is recalling 96 units of the MAYFIELD Composite Series Base Unit Standard, Model A3101. These medical devices are intended to support patients during diagnostic examinations and surgical procedures where rigid support between the surgical table and headrest or skull clamp is necessary.

The recall was initiated because Integra determined there is a possibility that the Base Units may break during use. The affected units were distributed worldwide, including to 31 U.S. states and Belgium.

Healthcare facilities and users should stop using the affected Base Units immediately. The specific serial numbers of the recalled units are listed in the official recall documentation.

The recalled product

Product: 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…
Manufacturer: Integra LifeSciences Corp.
Category: Medical Device — Surgical Support Equipment
Hazard: structural-failure
Affected units: 96

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model # A3101 Base Units Serial No's: SB120016
SB120017
SB120019
SB120020
SB120021
SB120022
SB120023
SB120024
SB120025
SB120026
SB120027
SB120028
SB120029
SB120030
SB120031
SB120032
SB120134
SB120036
SB120037
SB120038

Distribution

Distributed in 32 states:

Same manufacturer · Integra LifeSciences Corp.

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Same hazard · structural failure