Synthes TomoFix Osteotomy System Recalled for Surgical Technique Guide Labeling Error
Synthes USA HQ, Inc. is recalling the TomoFix Osteotomy System due to a labeling error in the Surgical Technique Guide that may cause surgical delays.
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 that could cause a surgical delay, which fits the criteria for a moderate severity recall involving minor labeling errors or low-risk issues.
Plain-English summary
Synthes USA HQ, Inc. is recalling the Synthes TomoFix Osteotomy System (J5606-C) due to a labeling correction in the Surgical Technique Guide. The recall involves 2,912 units distributed nationwide in the United States, as well as in Canada and Mexico.
The labeling error relates to the potential for a surgical delay if a surgeon inserts superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present in the system. The product is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, and for the treatment of bone and joint deformities, fractures, and malalignment.
Healthcare providers and patients should contact Synthes USA HQ, Inc. for further information regarding this recall.
The recalled product
- Product
- Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 2,912
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 (1)
- J5606-C
Distribution
Distributed nationwide across the United States.
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