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Orthofix US LLC

Last updated September 17, 2026

Information

Country: US
Address: 3451 Plano Parkway, Lewisville, TX, 75056
Website: orthofix.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)527-0404
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2183449
DUNS Number: 927083808

Catalogue (8519)

Page 13 of 171

Device	Model / Reference	Registries	Class	Status
Phoenix Sfs	20-0260	FDA UDI	Class I	Active
Pillar Xl	73-5318	FDA UDI	Class II	Active
Firebird	44-3095	FDA UDI	Class II	Active
Forza Ptc	38-3009SP	FDA UDI	Class II	Active
Proview	70-1090	FDA UDI	Class I	Active
Pillar Sa	49-4116	FDA UDI	Class I	Active
Lonestar	84-7514	FDA UDI	Class II	Active
Forza	89-1812SP	FDA UDI	Class II	Active
Fenestrated Screws	36-4945	FDA UDI	Class II	Active
Forza Ptc	38-1712SP	FDA UDI	Class II	Active
Sfs	55-1068	FDA UDI	Class I	Active
Firebird	51-3495	FDA UDI	Class II	Active
Ascent Le	66-3626	FDA UDI	Class II	Active
Firebird Sfs	77-7790	FDA UDI	Class II	Active
Centurion	69-3334	FDA UDI	Class II	Active
Skyhawk	27-5435	FDA UDI	Class I	Active
Firebird Sfs	44-3045	FDA UDI	Class II	Active
Icon	54-4645	FDA UDI	Class II	Active
Icon Sfs, Sfs	54-2050	FDA UDI	Class II	Active
Firebird	44-2101	FDA UDI	Class II	Active
Sfs	55-1036	FDA UDI	Class I	Active
Forza Xp	28-3184	FDA UDI	Class II	Active
Pillar Al	48-4012	FDA UDI	Class II	Active
Firebird Sfs	90-4893	FDA UDI	Class I	Active
Pillar Xl	73-2213	FDA UDI	Class II	Active
Pillar Xl	73-1616	FDA UDI	Class I	Active
Construx - Mini Ptc	37-5013SP	FDA UDI	Class II	Active
Skyhawk	27-3545	FDA UDI	Class II	Active
Connector	79-8301	FDA UDI	Class I	Active
Firebird	51-3360	FDA UDI	Class II	Active
Firebird	55-5330	FDA UDI	Class II	Active
Janus	36-6202	FDA UDI	Class II	Active
Pillar Sa	49-1017	FDA UDI	Class I	Active
Firebird	44-7770	FDA UDI	Class II	Active
Firebird	52-2600	FDA UDI	Class II	Active
Phoenix SFS	20-8070	FDA UDI	Class II	Active
Firebird Sfs	450293-0001	FDA UDI	Class I	Active
Pillar Xl	73-5417	FDA UDI	Class II	Active
Pillar Sa	49-2114	FDA UDI	Class II	Active
Fenestrated Screws	36-4750	FDA UDI	Class II	Active
Forza Ptc	38-1807SP	FDA UDI	Class II	Active
Firebird SFS	77-8090	FDA UDI	Class II	Active
Ascent Le	66-3350	FDA UDI	Class II	Active
Skyhawk	27-1511	FDA UDI	Class II	Active
Skyhawk	27-2517	FDA UDI	Class II	Active
Physio-Stim	3303	FDA UDI	Class II	Active
Forza	89-0460	FDA UDI	Class I	Active
Pillar Tl	45-7314	FDA UDI	Class II	Active
Firebird	44-7330	FDA UDI	Class II	Active
Firebird Sfs	44-3560	FDA UDI	Class II	Active

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 3, 2025	Z-0896-2026	—	open, classified	Labeling contains claims that are not consistently present.
Nov 3, 2025	Z-0893-2026	—	open, classified	Labeling contains claims that are not consistently present.
Nov 3, 2025	Z-0895-2026	—	open, classified	Labeling contains claims that are not consistently present.
Nov 3, 2025	Z-0894-2026	—	open, classified	Labeling contains claims that are not consistently present.
Nov 3, 2025	Z-0891-2026	—	open, classified	Labeling contains claims that are not consistently present.
Nov 3, 2025	Z-0892-2026	—	open, classified	Labeling contains claims that are not consistently present.
Sep 19, 2025	Z-0478-2026	—	open, classified	Polyaxial screws do not meet performance standards.
Jun 24, 2025	Z-2555-2025	—	open, classified	A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.
Feb 20, 2025	Z-1432-2025	—	open, classified	The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.