Synthes Spinal Screws Recalled Due to Incorrect Diameter
Synthes (USA) Products LLC is recalling six 3.5mm spinal screws that measure 4.0mm in diameter. The product was distributed to New Jersey.
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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The source text does not report any injuries, illnesses, or fatalities, and the defect is a dimensional discrepancy rather than a contamination or structural failure leading to immediate harm.
Plain-English summary
Synthes (USA) Products LLC is recalling six units of Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026. These medical devices are intended for use in spinal surgery.
The recall was initiated because the subject product measures 4.0mm in diameter instead of the specified 3.5mm. This dimensional discrepancy is the reason for the recall.
The affected units were distributed to New Jersey. The recall code is 10L2702. Healthcare providers and patients should verify the diameter of any installed or pending screws to ensure they match the 3.5mm specification.
The recalled product
- Product
- Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 6
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)
- 10L2702
Distribution
Distributed in 1 state:
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