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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 4 of 171

Device	Model / Reference	Registries	Class	Status
Forza	89-1609SP	FDA UDI	Class II	Active
Forza	89-7416SP	FDA UDI	Class II	Active
Firebird	44-5680 BE	FDA UDI	Class II	Active
Firebird	44-5875	FDA UDI	Class II	Active
Firebird	51-4365	FDA UDI	Class II	Active
Pillar Sa	49-9320	FDA UDI	Class I	Active
Fenestrated Screws	36-1606	FDA UDI	Class I	Active
Pillar Xl	73-1918	FDA UDI	Class I	Active
Forza	89-7708SP	FDA UDI	Class II	Active
Construx - Peek Vbr	45-2313	FDA UDI	Class II	Active
Ascent Le	66-3526	FDA UDI	Class II	Active
Ascent Le	65-5330	FDA UDI	Class II	Active
Icon	54-4465	FDA UDI	Class II	Active
Skyhawk	27-4144	FDA UDI	Class II	Active
Proview	90-2124	FDA UDI	Class I	Active
Pillar Al	48-4116	FDA UDI	Class II	Active
Hallmark	62-6704	FDA UDI	Class II	Active
Centurion	69-2020	FDA UDI	Class II	Active
Proview	70-1411	FDA UDI	Class II	Active
Fenestrated Screws	36-4440	FDA UDI	Class II	Active
Ascent Le	66-3853	FDA UDI	Class I	Active
Firebird	51-6423	FDA UDI	Class II	Active
Forza Ptc	38-1808SP	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	56-3425	FDA UDI	Class II	Active
Lonestar	83-3510	FDA UDI	Class II	Active
Skyhawk	27-3649	FDA UDI	Class II	Active
Firebird Sfs	54-1068	FDA UDI	Class I	Active
Skyhawk	27-3350	FDA UDI	Class II	Active
Firebird	77-7745	FDA UDI	Class II	Active
Pillar Tl	46-1047	FDA UDI	Class I	Active
Firebird Nxg	450466-0001	FDA UDI	Class I	Active
Skyhawk	27-4241	FDA UDI	Class II	Active
Firebird	77-7610	FDA UDI	Class II	Active
Pillar Tl	41-1063	FDA UDI	Class I	Active
Firebird	77-8890	FDA UDI	Class II	Active
Construx - Peek Vbr	45-6310	FDA UDI	Class II	Active
Skyhawk	27-5239	FDA UDI	Class I	Active
Centurion	69-1001	FDA UDI	Class I	Active
Lonestar	83-9126	FDA UDI	Class I	Active
Lonestar	84-5310	FDA UDI	Class II	Active
Centurion	69-2110	FDA UDI	Class II	Active
Skyhawk	27-5235	FDA UDI	Class I	Active
Proview	70-5002	FDA UDI	Class I	Active
Icon	68-9000	FDA UDI	Class II	Active
Construx - Mini Ptc	37-3009SP	FDA UDI	Class II	Active
Firebird	77-8740	FDA UDI	Class II	Active
Firebird	44-5185 AF	FDA UDI	Class II	Active
Janus	36-3465	FDA UDI	Class II	Active
Pillar Pl	46-1034	FDA UDI	Class I	Active
Firebird	51-4690	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.