FDA Device recall Z-2941-2024
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
- FDA Device
- Class II
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class II recall of FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System by Orthopediatrics Canada Ulc, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2941-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-04 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Orthopediatrics Canada Ulc |
| Distribution | US |
Product
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.
Identifiers
| code_info | Part Number FRT250; Lot Numbers: F281-04, F462-02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2941-2024%22
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