Pega Medical Recalls Fassier-Duval Intramedullary Rods Due to Material Defect
Pega Medical Inc. is recalling five units of the Fassier-Duval IM Telescopic System because the male components were made with material of lower strength than specifications.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the defect involves a structural material strength issue in an orthopedic implant, which aligns with the rubric criteria for Severe severity (structural defect/significant injury risk).
Plain-English summary
Pega Medical Inc. is recalling five units of the Fassier-Duval IM Telescopic System, specifically the male component (solid shaft) orthopedic intramedullary rods. The affected units are identified by Part number M040-SS-110 and Implant Catalogue number FD-040(LS)-SS. The recall covers two units in the United States and three units in Germany.
The recall was initiated because the male components in the affected lots were manufactured using material with lower strength than the required manufacturing specifications. The affected lots are identified as Lot # 130424-15 and Lot # 121109-11. These units were distributed in the United States (Missouri and Texas) and Germany.
Healthcare providers and patients should contact Pega Medical Inc. for further instructions regarding the return or replacement of these devices. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the device could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.
- Manufacturer
- Pega Medical Inc.
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 #: 130424-15 (only laser marked on the Part Number: M040-SS-110)
Distribution
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