Synthes Tensioning Device Recalled Due to Potential Mechanical Failure
Synthes USA HQ, Inc. is recalling 369 Tensioning Devices because the reaction fork may come loose, preventing the device from applying tension or releasing the wire.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Synthes USA HQ, Inc. is recalling 369 units of the Synthes Tensioning Device, part of the Synthes Osteogenesis System. The device is intended for fracture fixation, limb lengthening, and correction of bony or soft tissue deformities in adult and pediatric patients. The recall covers all lots of model number 03.311.001, which were distributed nationwide.
The recall was initiated due to a potential mechanical defect where the reaction fork may come loose from the main body of the device. If this occurs, the device may fail to apply tension or release the wire as intended. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare providers and patients should contact Synthes USA HQ, Inc. for instructions on how to handle the recalled devices. The recall number for this action is Z-0388-2014.
The recalled product
- Product
- Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue…
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 369
Distribution
Distributed nationwide across the United States.
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