Recall Z-0558-2013— Integra LifeSciences Corporation

Class II FDA medical device recall by Integra LifeSciences Corporation, initiated 2012-11-05, terminated 2014-02-21. FDA's recall record names no specific 510(k) clearance for this event. Product: MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory 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. A Swivel Adaptor (A3018) is an integral component of the Base Unit A3101.. Reason: An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d.

Recalling firm

Integra LifeSciences Corporation

Classification

Class II

Status

Terminated

Initiated

2012-11-05

Terminated

2014-02-21

Firm location

Cincinnati, OH, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.