Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MAYFIELD Composite Series Skull Clamps Recalled by Integra LifeSciences Corporation Due to An investigation of an adverse trend of complaints...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corporation directly.
Affected Products
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.
Quantity: eight (8) skull clamps were distributed
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Integra LifeSciences Corporation
Integra LifeSciences Corporation has 29 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report