Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synthes External Fixation Systems (Small Recalled by Synthes, Inc. Due to Labeling changes have been made related to MR...
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 Synthes, Inc. directly.
Affected Products
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Quantity: 5,114,052
Why Was This Recalled?
Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Synthes, Inc.
Synthes, Inc. has 43 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report