Recall Z-0559-2013— Integra LifeSciences Corporation

Name: FDA recall Z-0559-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-05

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corporation, initiated 2012-11-05, terminated 2014-02-21. It names one FDA 510(k) clearance: K120633. Product: MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.. 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

510(k) clearances named in this recall

1 on FDA's record

K120633 — MAYFIELD SKULL CLAMPIntegra LifeSciences Corporation·cleared 2012-05-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

Reason for recall

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

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