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Synthes, Inc. recalls Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Recalled June 25, 2014 · FDA recall Z-1833-2014 · Synthes
Hazard
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. · FDA Class II
Units
5,114,052
Sold at
Worldwide Distribution - USA (nationwide) and Canada.
Description
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.
Product
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Manufacturer(s)
Synthes, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →