FX SOLUTIONS devices, product family

by FX SOLUTIONSand 1 other manufacturer record 19 variants Basic UDI-DI 37010373TRIAHDF7

Shared by every variant

Manufacturer: FX SOLUTIONS(15)FX Shoulder Solutions(4)
Several manufacturer records share this Basic UDI-DI.
Basic UDI-DI: 37010373TRIAHDF7
Risk class: Class IIClass IIa (varies)
Legislation: MDR
EMDN category: ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER
Market status: 19 on the market
Official record: EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 37010373TRIAHDF7.

Recalls

2 recalls · FDA

Z-2469-2018 Class II · terminated · 4 Jun 2018
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
Z-2468-2018 Class II · terminated · 4 Jun 2018
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.

Recalls matched to the 19 devices listed on this page; other pages of the family can carry others.

Variants

19 devices · page 1 of 1

Variants of FX SOLUTIONS devices, Basic UDI-DI 37010373TRIAHDF7
		UDI-DI	Size and differences
FX SOLUTIONS 926-1013 FX SOLUTIONS	926-1013 / 926-1013	03701037303610	Prescription: no	On the market
Humelock Cemented Shoulder Prosthesis 926-1005 FX SOLUTIONS	926-1005 / 926-1005	03701037306949	Outer Diameter 41 mm Prescription: yes	On the market
Humelock Cemented Shoulder Prosthesis 926-1006 FX SOLUTIONS	926-1006 / 926-1006	03701037306956	Outer Diameter 48 mm Prescription: yes	On the market
Humelock Cemented Shoulder Prosthesis 926-1007 FX SOLUTIONS	926-1007 / 926-1007	03701037306963	Outer Diameter 54 mm Prescription: yes	On the market
Humelock Cemented Shoulder Prosthesis 926-1008 FX SOLUTIONS	926-1008 / 926-1008	03701037303566	Prescription: no	On the market
Humelock Cemented Shoulder Prosthesis 926-1009 FX SOLUTIONS	926-1009 / 926-1009	03701037303573	Prescription: no	On the market
Humelock Cemented Shoulder Prosthesis 926-1010 FX SOLUTIONS	926-1010 / 926-1010	03701037303580	Prescription: no	On the market
Humelock Cemented Shoulder Prosthesis 926-1011 FX SOLUTIONS	926-1011 / 926-1011	03701037303597	Prescription: no	On the market
Humelock Cemented Shoulder Prosthesis 926-1012 FX SOLUTIONS	926-1012 / 926-1012	03701037303603	Prescription: no	On the market
Humelock Cemented Shoulder Prosthesis 926-1014 FX SOLUTIONS	926-1014 / 926-1014	03701037303627	Prescription: no	On the market
Humelock Cemented Shoulder Prosthesis 926-1015 FX SOLUTIONS	926-1015 / 926-1015	03701037303634	Prescription: no	On the market
Humelock Cemented Shoulder Prosthesis 926-1017 FX SOLUTIONS	926-1017 / 926-1017	03701037306987	Outer Diameter 41 mm Prescription: yes	On the market
Humelock Cemented Shoulder Prosthesis 926-1018 FX SOLUTIONS	926-1018 / 926-1018	03701037306994	Outer Diameter 48 mm Prescription: yes	On the market
Humelock II Cementless Shoulder System 926-1019 FX SOLUTIONS	926-1019 / 926-1019	03701037303641	Prescription: no	On the market
Humelock II Cementless Shoulder System 926-1026 FX SOLUTIONS	926-1026 / 926-1026	03701037303658	Prescription: no	On the market
TRIAL HEAD FX Shoulder Solutions	916-0048	03701037308301	—	On the market
TRIAL HEAD FX Shoulder Solutions	916-0051	03701037308318	—	On the market
TRIAL HEAD FX Shoulder Solutions	916-0054	03701037308325	—	On the market
TRIAL HEAD FX Shoulder Solutions	926-1025	03701037307007	—	On the market