Recall Z-2941-2024 ยท LXH Orthopedic Manual Surgical Instrument
ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
| Date | Aug 29, 2024 (initiated Jul 4, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| 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. |
| Quantity | 6 units |
| Distribution | Worldwide - US Nationwide distribution in the state of Texas and the countries of United Arab Emirates, Brazil, Canada, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041393 | FASSIER-DUVAL TELSCOPIC IM SYSTEM Pega Medical, Inc., Aug 17, 2004 |