Composite Series Skull Clamp — Class II medical device recall Z-0210-2014
Terminated recall by Integra LifeSciences Corp., reported 2013-11-20, distributed in AL, AR, CA, CT, FL, GA, IA, IL…. An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking
| Recall number | Z-0210-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2013-08-29 |
| Classified | 2013-11-13 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2014-01-14 |
| Distributed | AL, AR, CA, CT, FL, GA, IA, IL, MS, NY, OH, SC, TN, TX |
| Quantity | 37 units |
| Reason classes | device malfunction |
Product
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 for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.