Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Orthofix Power Drill Torque Limiter Recalled by Orthofix Srl Due to The power drill torque limiter may break during...
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 Orthofix Srl directly.
Affected Products
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
Quantity: 416 units
Why Was This Recalled?
The power drill torque limiter may break during use in surgery application.
Where Was This Sold?
This product was distributed to 3 states: CA, FL, PA
About Orthofix Srl
Orthofix Srl has 34 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report