Synthes 3.0mm Headless Compression Screws Recalled for Labeling Mismatch
Synthes (USA) Products LLC is recalling 20 units of 3.0mm Headless Compression Screws because the product inside the package does not match the label.
What this means for you
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 where the product does not match the label. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving minor labeling errors or low-risk contamination.
Plain-English summary
Synthes (USA) Products LLC is recalling 20 units of 3.0mm Headless Compression Screws, Long Thread 18mm, Part Number 04.226.118, Lot Number L734474. These medical devices are intended for the fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
The recall was initiated because the product inside the package does not match the label. Specifically, the screws were labeled as long thread screws with a 6mm thread length, but they were actually short thread screws with a 4mm thread length.
The affected units were distributed in the United States to the states of Arkansas, Arizona, Florida, Illinois, New Mexico, Ohio, and Texas. Consumers and healthcare providers should stop using the affected products and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 20
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 Numbers: L734474
Distribution
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