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U.S. Department of Health and Human Services

Class 2 Device Recall MAYFIELD Composite Series Skull Clamp

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  Class 2 Device Recall MAYFIELD Composite Series Skull Clamp see related information
Date Initiated by Firm August 29, 2013
Date Posted November 13, 2013
Recall Status1 Terminated 3 on January 14, 2014
Recall Number Z-0210-2014
Recall Event ID 66449
510(K)Number K120633  
Product Classification Holder, head, neurosurgical (skull clamp) - Product Code HBL
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
Code Information 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
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Integra Customer Service
855-532-1723
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HBL and Original Applicant = INTEGRA LIFESCIENCES CORPORATION
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