Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Tele
FDA device recall Z-1472-2014 · posted 2014-04-18 · Terminated
Recall details
- Recalling firm
- Pega Medical Inc.
- 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.
- Action taken
- There is an error on the outside label of the implant. The length was mistaken on the label. It was indicated 245mm instead of 338mm. It has to be clarified that the Fassier-Duval implant is provided with two labels, one that is outside the tube used for packaging and one inside the tube.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 48
- Distribution
- Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.
- Date initiated
- 2014-03-05
- Date posted
- 2014-04-18
- Date terminated
- 2014-05-19
- Location
- Laval, Canada
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FASSIER-DUVAL TELSCOPIC IM SYSTEM (K041393) | Pega Medical, Inc. | 2004-08-17 |
| FASSIRE-DUVAL TELESCOPIC IM SYSTEM (K020885) | Pega Medical, Inc. | 2003-02-06 |