FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
FDA device recall Z-2941-2024 · posted 2024-08-29 · Open, Classified
Recall details
- Recalling firm
- ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
- Reason for recall
- During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.
- Action taken
- On about 07/04/2024, Orthopediatrics notified consignees via email. Consignees were instructed to identify any affected units and spare parts within inventory, contact Customer Service, and arrange for return of affected units. Consignees were also instructed to notify all applicable personnel or customers if further distributed or transferred.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LXH
- Quantity affected
- 6 units
- Distribution
- Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.
- Date initiated
- 2024-07-04
- Date posted
- 2024-08-29
- 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 |