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U.S. Department of Health and Human Services

Class 2 Device Recall MAYFIELD Skull Clamps

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  Class 2 Device Recall MAYFIELD Skull Clamps see related information
Date Initiated by Firm November 05, 2012
Date Posted December 19, 2012
Recall Status1 Terminated 3 on February 21, 2014
Recall Number Z-0559-2013
Recall Event ID 63776
510(K)Number K120633  
Product Classification Holder, head, neurosurgical (skull clamp) - Product Code HBL
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.
Code Information The recalled product is identified with the Lot Numbers: 096455 and 097546.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corporation
4900 Charlemar Dr Bldg A
Cincinnati OH 45227-1402
For Additional Information Contact Michael Molloy
513-533-7979
Manufacturer 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
FDA Determined
Cause 2		 Under Investigation by firm
Action Integra issued an 'Urgent: Voluntary Medical Device Recall Notification with 'Recall Acknowledgment and Return Form' to all Integra Sales Representatives and Customers via visit and E-mail on November 5, 2012. The recall notice informs the customers of the firm's receipt of complaints pin-pointing quality issues with the MAYFIELD Base Units and MAYFIELD Skull Clamps which may impair their functionality. The customers are asked to sign and return the enclosed Recall Acknowledgement and Return Form so as to document their receipt of the recall notification and replacement products. The replacement products are to be delivered by the Integra NeuroSpecialist who is also responsible for returning the signed forms to Integra as documentation that the recalled devices have been replaced. Should the customer(s) have questions or concerns, they are directed to contact Integra Customer Service at: 1-877-444-1114,Option 3 for Technical Support.
Quantity in Commerce eight (8) skull clamps were distributed
Distribution Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.
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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