Synthes Large External Fixation Tube to Tube Clamp Recalled for Incorrect Insert
Synthes USA HQ, Inc. is recalling 8 units of Large External Fixation Tube to Tube Clamps because the provided insert incorrectly states the device is MR Safe instead of MR Conditional.
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. The hazard involves a labeling discrepancy regarding MRI safety status (MR Safe vs. MR Conditional) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Synthes USA HQ, Inc. is recalling 8 units of Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599. The product is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
The recall was initiated after an internal investigation discovered a discrepancy between the insert provided with the device and the Bill of Materials. It was determined that the incorrect insert was used, which indicates the device is MR Safe when it is actually MR Conditional.
The affected units were distributed in the United States, including the states of California, Minnesota, North Carolina, and Tennessee. Users should stop using the affected devices and contact Synthes USA HQ, Inc. for further instructions.
The recalled product
- Product
- Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
- 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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