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

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.

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

Distribution pattern: US Distribution including the states of AL, AR, CA, CT, FL, GA, IA, IL, MS, NY, OH, SC, TN, and TX.