Recall Z-0210-2014— Integra LifeSciences Corp.

Name: FDA recall Z-0210-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-29

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2013-08-29, terminated 2014-01-14. It names one FDA 510(k) clearance: K120633. Product: Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is 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 for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. None of the complaints resulted in a report of patient injury, adverse health consequence, or a delay / prolongation of the surgical procedure..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-08-29
Terminated: 2014-01-14
Firm location: Plainsboro, NJ, 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

Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is 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 for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. None of the complaints resulted in a report of patient injury, adverse health consequence, or a delay / prolongation of the surgical procedure.

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