Recall Z-1448-2014 ยท HSB Rod, Fixation, Intramedullary And Accessories
Pega Medical Inc.
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.
| Date | Apr 10, 2014 (initiated Feb 7, 2014) |
| Status | Terminated |
| Reason | The Male Components in this lot are made of material with lower strength than manufacturing specifications. |
| Root cause | Nonconforming Material/Component |
| Action | Pega Medical sent an Urgent Field Safety Notice-Recall letter dated February 7, 2014, to their customers via email. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to identify the affected devicee, verify if it was used in a patient and place the affected device in quarantine immediately if not used. If not used, return the affected device to Pega Medical Inc. to the address provided. Pega's customer notification stated "If used, it is recommended to continue the normal patient follow up. Customers with questio |
| Quantity | Total of 5 units (2 units in the US and 3 units in Germany) |
| Distribution | Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany. |
| FDA record | Open on fda.gov |