Synthes Maxillary Plates Recalled for Incorrect Laser Etch Orientation
Synthes (USA) Products LLC is recalling 31 pre-bent maxillary plates due to potential incorrect laser etch denoting orientation.
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/etching error (incorrect orientation) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Synthes (USA) Products LLC is recalling 31 units of Synthes TI Matrix Pre-Bent Maxillary Plates, specifically the 2mm ADVMNT/0.8mm THK/L and 2mm ADVMNT/0.8mm THK/R models. The recall affects part numbers 04.511.381 and 04.511.382, with lot numbers 8672528, 8673158, and 8672260.
The recall was initiated because the affected parts and lot numbers may potentially have the incorrect laser etch denoting the orientation. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton, craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible, and chin in adults and children.
The products were distributed nationwide, including in California, Utah, Colorado, New Jersey, Washington, Vermont, Kentucky, Wyoming, Connecticut, New York, Mississippi, and Maryland. Healthcare providers and patients should contact Synthes (USA) Products LLC for further instructions regarding the affected devices.
The recalled product
- Product
- Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 31
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)
- Part Numbers: 04.511.381 04.511.382 Lot Numbers: 8672528 8673158 & 8672260
Distribution
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