Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Manual trephines are bone cutting and drilling instruments that are Recalled by Instrumed International, Inc. Due to The reason these devices are being withdrawn from...
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 Instrumed International, Inc. directly.
Affected Products
Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.
Quantity: 74 trephines
Why Was This Recalled?
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Instrumed International, Inc.
Instrumed International, Inc. has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report