Synthes 3.2 mm Guide Wire Recalled for Incorrect Raw Material Labeling
Synthes, Inc. is recalling 3.2 mm Guide Wires because the label lists an incorrect raw material. The recall covers units distributed in the USA, Canada, and Switzerland.
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 specific defect is a labeling error regarding raw material composition. This aligns with the rubric for minor labeling errors or voluntary precautionary recalls where no immediate physical hazard is described.
Plain-English summary
Synthes, Inc. is recalling the Synthes 3.2 mm Guide Wire 400mm. The recall is due to an incorrect raw material listed on the product label. These guide wires are used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
The recall involves 1,132,096 units. The affected products are identified by part No. 357.399 with specific lot numbers ranging from 4440270 through 7531836, as well as UK and UL series numbers. The products were distributed nationwide in the United States, as well as in Canada and Switzerland.
Healthcare providers and facilities should check their inventory for the affected part and lot numbers. Consumers should not use the recalled guide wires and should contact Synthes, Inc. for further instructions or a replacement.
The recalled product
- Product
- Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 1,132,096
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 (9)
- part No. 357.399 with all lot numbers 4440270 through 49991803
- 5000218 through 5894644
- 6000409 through 6999404
- 7000143 through 7531836
- UK09636
- UK10233
- UK10510
- UL11099
- and UL11333.
Distribution
Distributed nationwide across the United States.
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