Synthes Threaded Plate Holder Recalled for Incorrect Part Number Etching
Synthes (USA) Products LLC is recalling 25 units of Threaded Plate Holders that are incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.
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 hazard is a labeling error (incorrect etching) that may cause a fit issue, with no reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Synthes (USA) Products LLC is recalling 25 units of the Synthes Threaded Plate Holder- Long for 3.5mm Locking Hole, Part Number 324.031, Lot Number 8225613. The product is a medical device used to position plates on bone and as an insertion handle for minimally invasive plating techniques.
The recall was initiated because the affected units are incorrectly etched with the wrong part number. This labeling error may cause the device to not fit into a Small Fragment Plate.
The affected products were distributed worldwide, including nationwide in the United States and in Canada. Users should stop using the affected devices and contact the recalling firm for further instructions.
The recalled product
- Product
- Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques.…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 25
Distribution
Distributed nationwide across the United States.
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