FRT250 — Class II medical device recall Z-2941-2024
Ongoing recall by ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL, reported 2024-09-04, distributed nationwide. During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT24
| Recall number | Z-2941-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL, Laval, Canada |
| Recall initiated | 2024-07-04 |
| Classified | 2024-08-29 |
| Reported by FDA | 2024-09-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BR, CA, NL |
| Quantity | 6 units |
| Lot numbers | F281-04, F462-02 |
| Model numbers | FRT250 |
Product
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2941-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.