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.

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

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.