Synthes Mandible External Fixator Recalled for Incorrect MR Safe Labeling
Synthes, Inc. is recalling Mandible External Fixators because updated testing protocols mean the devices can no longer be designated MR Safe, despite previous labeling.
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 describes a labeling discrepancy regarding MR safety rather than a structural defect or reported injury. This aligns with the rubric for moderate severity involving labeling errors or precautionary measures without reported harm.
Plain-English summary
Synthes, Inc. is recalling the Synthes Mandible External Fixator. This recall affects all lots of specific part numbers, including 04.305.003, 04.305.004, and 04.305.005, among others. The devices are intended to stabilize and treat fractures of the maxillofacial area, including severe open mandibular fractures and nonunions. Approximately 43,159 units were distributed worldwide.
The recall is due to changes in testing protocols for Magnetic Resonance (MR) Environment safety and compatibility. Under these new protocols, metal devices are no longer designated as MR Safe. Some components in the affected fixator systems were previously labeled or etched with information indicating they were MR Safe. The manufacturer states that these components can no longer be labeled as MR Safe.
Healthcare facilities and users should stop using the affected devices for MR imaging if they rely on the previous MR Safe designation. Users should contact Synthes, Inc. for further instructions on how to handle the recalled units.
The recalled product
- Product
- The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142…
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 43,159
Distribution
Distribution scope not specified by the agency.
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