Synthes Matrix Threaded Persuader Recalled Due to Reduction Insert Breakage
Synthes USA HQ, Inc. is recalling 634 units of the Matrix Threaded Persuader because the Reduction Insert can break during use, preventing the instrument from functioning.
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 functional malfunction (breakage) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Synthes USA HQ, Inc. is recalling 634 units of the Synthes Matrix Threaded Persuader Deformity, a thoracolumbar pedicle screw system. The recall is due to a malfunction where the Reduction Insert can break off during a procedure. Once the Reduction Insert breaks, the instrument will not function as required.
The affected products were distributed worldwide, including in the United States, Canada, and Switzerland. The recall covers specific item lot numbers associated with the product code 03.632.008.
Healthcare providers and consumers should stop using the affected devices and contact Synthes USA HQ, Inc. for instructions on return or replacement.
The recalled product
- Product
- Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 634
Distribution
Distributed nationwide across the United States.
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