Pega Medical Recalls Fassier-Duval IM Telescopic System Due to Labeling Error
Pega Medical Inc. is recalling 48 units of the Fassier-Duval IM Telescopic System because the outer package label listed the incorrect device length.
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 is a minor labeling error regarding device length without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Pega Medical Inc. is recalling 48 units of the Fassier-Duval IM Telescopic System, an orthopedic intramedullary rod implant. The recall was initiated because the outer package label contained the incorrect length of the device. The product is identified by Catalogue Number FD-040(L)-SS and specific lot numbers including 111208-03, 110808-13, 111019-01, and 110302-01.
The affected devices were distributed worldwide, including in the United States, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain. The source text notes that there is a label on the outer package and an additional label on the product contained within the package.
Healthcare providers and consumers should verify the device length against the label on the product itself rather than relying solely on the outer package label. Pega Medical Inc. is the recalling firm responsible for this action.
The recalled product
- Product
- Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
- Manufacturer
- Pega Medical Inc.
- Hazard
- Affected units
- 48
Distribution
Distributed nationwide across the United States.
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