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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 2 of 171

Device	Model / Reference	Registries	Class	Status
Pillar Xl	72-4220	FDA UDI	Class I	Active
Forza Ptc	38-1008SP	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	58-3550	FDA UDI	Class II	Active
Firebird	77-7450	FDA UDI	Class II	Active
Pillar Sa	450263-0001	FDA UDI	Class I	Active
Forza Ptc	38-4010SP	FDA UDI	Class II	Active
Proview	70-1343	FDA UDI	Class I	Active
Sfs	55-5125	FDA UDI	Class II	Active
Firebird Sfs	52-1890	FDA UDI	Class I	Active
Firebird	77-8545 BE	FDA UDI	Class II	Active
Skyhawk	27-1676	FDA UDI	Class II	Active
Skyhawk	27-3615	FDA UDI	Class II	Active
Skyhawk	27-1641	FDA UDI	Class II	Active
Forza	89-0365	FDA UDI	Class I	Active
Sfs	55-1038	FDA UDI	Class I	Active
Lonestar	83-9003	FDA UDI	Class I	Active
Unity	43-0099	FDA UDI	Class I	Active
Skyhawk	24-5560	FDA UDI	Class II	Active
Firebird	44-5750 BE	FDA UDI	Class II	Active
Cetra	19-3013	FDA UDI	Class II	Active
Firebird	44-5960 AF	FDA UDI	Class II	Active
Skyhawk	27-1549	FDA UDI	Class II	Active
Janus	36-2445	FDA UDI	Class II	Active
Skyhawk	27-1614	FDA UDI	Class II	Active
Skyhawk	27-4647	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-3870	FDA UDI	Class II	Active
Centurion	69-8208	FDA UDI	Class I	Active
Firebird	51-3510	FDA UDI	Class II	Active
Firebird Sfs	450351-0001	FDA UDI	Class I	Active
Skyhawk	27-5612	FDA UDI	Class I	Active
Firebird	44-5630 BE	FDA UDI	Class II	Active
Icon	54-3455	FDA UDI	Class II	Active
Pillar Al	48-3008	FDA UDI	Class II	Active
Firebird	51-4310	FDA UDI	Class II	Active
Construx - Mini Peek Vbr	47-4012	FDA UDI	Class II	Active
Firebird	44-5890 BE	FDA UDI	Class II	Active
Forza	89-1009SP	FDA UDI	Class II	Active
Pillar Xl	73-5319	FDA UDI	Class II	Active
Forza	87-7616SP	FDA UDI	Class II	Active
Forza	87-4309SP	FDA UDI	Class II	Active
Skyhawk	27-4515	FDA UDI	Class II	Active
Pillar Sa	49-2014	FDA UDI	Class II	Active
Janus	36-2625	FDA UDI	Class II	Active
Skyhawk	27-3179	FDA UDI	Class II	Active
Skyhawk	27-2479	FDA UDI	Class II	Active
Forza	89-0370	FDA UDI	Class I	Active
Pillar Xl	72-1615	FDA UDI	Class I	Active
Skyhawk	27-3276	FDA UDI	Class II	Active
Skyhawk	27-3342	FDA UDI	Class II	Active
Forza	89-0254	FDA UDI	Class I	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.