Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Extremity Medical Recalled by Extremity Medical LLC Due to Lag screw measurement is short (approximately 5 mm)...
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 Extremity Medical LLC directly.
Affected Products
Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device.
Quantity: 93 units
Why Was This Recalled?
Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Extremity Medical LLC
Extremity Medical LLC has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report