Recall Z-0559-2013 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
Integra LifeSciences Corporation
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.
| Date | Dec 19, 2012 (initiated Nov 5, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 repla |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120633 | MAYFIELD SKULL CLAMP Integra LifeSciences Corporation, May 24, 2012 |