FDA Medical Device Recalls (openFDA)
Pega Medical Inc.: Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
- Recall number
- Z-1472-2014
- Recalling firm
- Pega Medical Inc.
- Product
- Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
- Status
- Terminated
- Initiated
- 2014-03-05
- Posted
- 2014-04-18
- Terminated
- 2014-05-19
- Reason
- 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.
- Root cause
- Error in labeling
- Action
- 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.
- Quantity
- 48
- Distribution
- Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.
- Lot, serial or model codes
- Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13
- 510(k) numbers
- ["K020885","K041393"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3000327445
- Firm city
- Laval
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28