FDA Medical Device Recalls (openFDA)
Pega Medical Inc.: 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.
- Recall number
- Z-1448-2014
- Recalling firm
- Pega Medical Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2014-02-07
- Posted
- 2014-04-10
- Terminated
- 2014-04-23
- Reason
- The Male Components in this lot are made of material with lower strength than manufacturing specifications.
- Root cause
- Nonconforming Material/Component
- Action
- Pega Medical sent an Urgent Field Safety Notice-Recall letter dated February 7, 2014, to their customers via email. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to identify the affected devicee, verify if it was used in a patient and place the affected device in quarantine immediately if not used. If not used, return the affected device to Pega Medical Inc. to the address provided. Pega's customer notification stated "If used, it is recommended to continue the normal patient follow up. Customers with questions should call (450) 688-5144 ext. 242 or email egarcia@pegamedical.com
- Quantity
- Total of 5 units (2 units in the US and 3 units in Germany)
- Distribution
- Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.
- Lot, serial or model codes
- Lot #: 130424-15 (only laser marked on the Part Number: M040-SS-110); Lot #: 121109-11 &130424-15 [Indicated on the label of the Catalogue Number: FD-040(L)-SS].
- 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