Device 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.
Z-1448-2014
Product summary
- Event
- Event 67675
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total of 5 units (2 units in the US and 3 units in Germany)
- Official record key
device-enforcement:Z-1448-2014
Official wording
Reason: The Male Components in this lot are made of material with lower strength than manufacturing specifications.
Code information: Lot #: 130424-15 (only laser marked on the Part Number: M040-SS-110); Lot #: 121109-11 &130424-15 [Indicated on the label of the Catalogue Number: FD-040(L)-SS].
Distribution pattern: Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.
Derived failure modes
-
Unknown
The Male Components in this lot are made of material with lower strength than manufacturing specifications.