FDA Recall
Open, Classified
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Recall: Z-2941-2024
·
Initiated July 4, 2024
Recall
- Recall Number
- Z-2941-2024
- Event Number
- 95077
- Firm
- ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL 1111 Chomedey (A-13) E Laval Canada
- FEI Number
- 3000327445
- Product Code
- LXH
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- July 4, 2024
- Posted
- August 29, 2024
Description
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Reason
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
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.
Distribution
Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands.
Quantity
6 units