Drug recall
Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic…
FDA recall event 71061 · Class II · Pega Medical Inc.
Key facts
| Event ID | 71061 |
|---|---|
| Recall numbers | Z-1546-2015 |
| Recalling firm | Pega Medical Inc. |
| Product type | Devices |
| Products | Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the… |
| Initiation date | Apr 10, 2015 |
| Report date | May 6, 2015 |
| Termination date | Jun 29, 2015 |
| 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: