Synthes External Fixation Clamp Recalled for Incorrect MR Safety Labeling
Synthes USA HQ, Inc. is recalling 8 units of External Fixation System Tube to Tube Clamps because the provided insert incorrectly states the product is MR safe, while the device is actually MR Conditional.
What this means for you
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 and involves a labeling error regarding MR safety. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate (Score 2).
Plain-English summary
Synthes USA HQ, Inc. is recalling 8 units of the Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007, Lot number 6800599. The product is intended for the treatment of long bone and pelvic fractures that require external fixation. The recall is due to a labeling error where the insert provided with the product incorrectly indicates that the device is MR safe. The device itself is etched as MR Conditional, meaning the insert contains incorrect information regarding its safety in magnetic resonance imaging environments.
The affected units were distributed nationwide, including in the states of California, Minnesota, North Carolina, and Tennessee. This recall is classified as Class II by the U.S. Food and Drug Administration. No specific dates of distribution or additional geographic details are provided in the source text.
Healthcare facilities and consumers who possess this specific lot of the Synthes External Fixation System Tube to Tube Clamp should stop using the product and contact Synthes USA HQ, Inc. for further instructions on how to return the device. The primary hazard is the potential for misuse of the device in an MRI environment due to the conflicting safety information provided in the insert versus the device etching.
The recalled product
- Product
- Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytra
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part number 390.007
- Lot number 6800599
Distribution
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