Drug recall
Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110…
FDA recall event 67675 · Class II · Pega Medical Inc.
Key facts
| Event ID | 67675 |
|---|---|
| Recall numbers | Z-1448-2014 |
| Recalling firm | Pega Medical Inc. |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Male Components in this lot are made of material with lower strength than manufacturing specifications. |
| Initiation date | Feb 7, 2014 |
| Report date | Apr 16, 2014 |
| Termination date | Apr 23, 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: