Recall Z-0210-2014 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
Integra LifeSciences Corp.
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 surge
| Date | Nov 13, 2013 (initiated Aug 29, 2013) |
| Status | Terminated |
| Reason | 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 | 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 S |
| Quantity | 37 units |
| Distribution | US Distribution including the states of AL, AR, CA, CT, FL, GA, IA, IL, MS, NY, OH, SC, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120633 | MAYFIELD SKULL CLAMP Integra LifeSciences Corporation, May 24, 2012 |