Synthes Recalls MatrixNEURO Screws Due to Incorrect Body Clip Labeling
Synthes, Inc. is recalling 104 units of MatrixNEURO 5mm screws because the body clip is etched with '4', incorrectly indicating a 4mm screw, despite correct outer packaging.
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 involves a labeling discrepancy that could lead to the use of an incorrect device size, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Synthes, Inc. is recalling 104 units of MatrixNEURO 5mm screws, Lot # 30P6198. The intended use for these devices is in the fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.
The recall was initiated because the screws were packaged in a body clip etched with the number "4", which indicates a 4mm screw. While the outer package labeling correctly identifies the screws as 5mm, the body clip incorrectly identifies a shorter length for the device.
The affected units were distributed internationally, including in Australia, Belgium, Chile, France, Slovakia, and South Korea. Healthcare providers and patients should verify the lot number and body clip markings of any MatrixNEURO screws in use to ensure they are not part of this recall.
The recalled product
- Product
- MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 104
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 # 30P6198
Distribution
Distribution scope not specified by the agency.
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