Synthes External Fixation Systems Recalled for MR Labeling Changes
Synthes, Inc. is recalling external fixation systems because labeling changes were made to reflect updated protocols for Magnetic Resonance (MR) imaging safety designations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is labeling changes related to MR protocols and does not report any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Synthes, Inc. is recalling Synthes External Fixation Systems (Small, Medium, Large and DO), which are bone fixation appliance components. The recall involves 5,114,052 units distributed nationwide in the United States and in Canada.
The reason for the recall is that labeling changes have been made related to Magnetic Resonance (MR) imaging conditions. These changes result from updates to required protocols for designating a product as MR Safe, MR Conditional, or MR Unsafe.
Healthcare facilities and consumers who have these products should check the labeling to ensure it reflects the correct MR safety designation. The source text does not specify further consumer actions or report any illnesses or injuries.
The recalled product
- Product
- Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 5,114,052
Distribution
Distributed nationwide across the United States.
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