Synthes Spine Pedicle Screw Recalled for Incorrect Length Etching
Synthes USA HQ, Inc. is recalling 18 units of 45 mm Click 'X Pedicle Screws because they were incorrectly etched as 40 mm.
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, and the hazard is a labeling error (incorrect length etching) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Synthes USA HQ, Inc. is recalling 18 units of the Synthes Spine 5.2mm Titanium Click 'X Pedicle Screw Dual Core, Part Number 487.072. The specific lot number is 7542279. These medical devices are intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
The recall was initiated because the 45 mm screws were incorrectly etched with the label "Click 'X Pedicle Screw 05.2 L40 TAN violet," which indicates a 40 mm length. This labeling error creates a discrepancy between the physical length of the screw and the information provided on the device.
The affected units were distributed in the states of Alabama, California, Mississippi, Missouri, New Jersey, Oregon, and Tennessee. Healthcare providers and facilities that have received these specific devices should stop using them and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 18
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)
- Lot Number 7542279
Distribution
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