Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
Product Codes/Lot Numbers:
Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1472-2014
Related Recalls
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
Pega Medical
Handle could jam with the Driver due to the detachment of an internal Connector Ring.