Drug recall
Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS…
FDA recall event 67803 · Class II · Pega Medical Inc.
Key facts
| Event ID | 67803 |
|---|---|
| Recall numbers | Z-1472-2014 |
| Recalling firm | Pega Medical Inc. |
| Product type | Devices |
| Products | Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package. |
| Initiation date | Mar 5, 2014 |
| Report date | Apr 30, 2014 |
| Termination date | May 19, 2014 |
| City | Laval |
| Country | Canada |
| FEI number | 3000327445 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: