Z-0210-2014Class II

Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a cranial stabilization...

Name: Z-0210-2014 Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a cranial stabilization...
Creator: Integra LifeSciences Corp.
Published: 2013-08-29
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2013-08-29 / Terminated / root cause: design

FDA source

Integra LifeSciences Corp. began a recall of Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal... on 2013-08-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0210-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-29
Posted: 2013-11-13
Terminated: 2014-01-14
Recalling firm: Integra LifeSciences Corporation
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
Product code: HBL Holder, Head, Neurosurgical (Skull Clamp)
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.
Root cause tag: design
FDA root cause: Device Design
Action: Integra sent an Urgent: Voluntary Medical Device Recall Notification dated August 29, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your local Integra NeuroSpecialist will set up a time with you to discuss replacement options but in the interim, Integra is asking that you do the following: 1. Review your inventory and determine if you have any MAYFIELD Composite Series Skull Clamps (A3059). If so, stop using them immediately and remove them from service to prevent any inadvertent use of the Composite Series Skull Clamp. Either while the Integra NeuroSpecialist is on-site or independently; 2. Complete the attached form. If you do not have affected product, check the box: I do not have Composite Series Skull Clamps. 3. If you do have affected product, check the box: I do have Composite Series Skull Clamps. Record the total quantity and Serial No.(s) of all Skull Clamps in your inventory. The Serial No. is located on the clamp upright comprised of two letters (SS) followed by six numerals. 4. Complete the other information and return by email or fax as indicated on the form, or give it to the Integra NeuroSpecialist who will return it for you. For assistance returning and exchanging these products or any other questions that you may have, please contact Integra Customer Service at 1-855-532-1723. We sincerely apologize for any inconvenience this may have caused and thank you for your cooperation.
Quantity in commerce: 37 units
Distribution: US Distribution including the states of AL, AR, CA, CT, FL, GA, IA, IL, MS, NY, OH, SC, TN, and TX.
Product codes and lots: The following serial numbers are affected by this recall: SS120076, SS120082, SS120083, SS120084, SS120088, SS120089, SS120090, SS120092, SS120093, SS120094, SS120095, SS120111, SS120112, SS120113, SS120114, SS120115, SS120116, SS120117, SS120118, SS120119, SS120120, SS120121, SS120122, SS120123, SS120124, SS120125, SS120126, SS120127, SS120128, SS120130, SS120131, SS120133, SS120134, SS120135, SS120171, SS120252, SS120256, SS120257

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0210-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0210-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13

Product code HBL

K120633Class IIMayfield Skull ClampIntegra LifeSciences Corporation / cleared 2012-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)