Recall Z-2941-2024— ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL

Name: FDA recall Z-2941-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-04

Class II · Ongoing

Class II FDA medical device recall by ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL, initiated 2024-07-04. It names one FDA 510(k) clearance: K041393. 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..

Recalling firm: ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
Classification: Class II
Status: Ongoing
Initiated: 2024-07-04
Firm location: Laval, Canada

510(k) clearances named in this recall

1 on FDA's record

K041393 — FASSIER-DUVAL TELSCOPIC IM SYSTEMPega Medical, Inc.·cleared 2004-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.