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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 10 of 171

Device	Model / Reference	Registries	Class	Status
Pemf - Physio-Stim	655302-0001	FDA UDI	Class III	Active
Sfs;sfs Le;sfs Scoli	58-3865	FDA UDI	Class II	Active
Proview	70-1412	FDA UDI	Class I	Active
Firebird Sfs	44-3011	FDA UDI	Class II	Active
Forza	89-7615SP	FDA UDI	Class II	Active
Pillar Xl	73-8109	FDA UDI	Class II	Active
Forza	89-7816SP	FDA UDI	Class II	Active
Cetra	19-6010	FDA UDI	Class II	Active
Pillar Tl	46-1065	FDA UDI	Class I	Active
Firebird	51-4350	FDA UDI	Class II	Active
Firebird	51-3475	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	55-4825	FDA UDI	Class II	Active
Construx - Peek Vbr	45-3341	FDA UDI	Class II	Active
Firebird Sfs	44-3111	FDA UDI	Class II	Active
Reliant	64-6684	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	55-4455	FDA UDI	Class II	Active
Skyhawk	27-4572	FDA UDI	Class II	Active
Forza	650727-0002	FDA UDI	Class II	Active
Forza	87-1309SP	FDA UDI	Class II	Active
Skyhawk	27-4676	FDA UDI	Class II	Active
Forza	88-2009SP	FDA UDI	Class II	Active
Firebird	61-7770	FDA UDI	Class II	Active
Pillar Sa	49-9618	FDA UDI	Class II	Active
Pillar Pl	46-1400	FDA UDI	Class I	Active
Forza Ptc	38-4208SP	FDA UDI	Class II	Active
Lonestar	83-3516	FDA UDI	Class II	Active
Sfs	55-1050	FDA UDI	Class I	Active
Construx - Peek Vbr	45-1057	FDA UDI	Class I	Active
Pillar Sa	49-9220	FDA UDI	Class II	Active
Construx - Mini Peek Vbr	47-4010	FDA UDI	Class II	Active
Construx - Mini Ptc	37-5806	FDA UDI	Class I	Active
Forza	89-5016SP	FDA UDI	Class II	Active
Skyhawk	27-4117	FDA UDI	Class II	Active
Forza;trinity Evolution	35-5002	FDA UDI	Class I	Active
Skyhawk	27-4538	FDA UDI	Class II	Active
Forza	87-7613SP	FDA UDI	Class II	Active
Skyhawk	27-4216	FDA UDI	Class II	Active
Firebird	44-3730	FDA UDI	Class II	Active
Skyhawk	27-2618	FDA UDI	Class II	Active
Firebird Sfs	450202-0001	FDA UDI	Class I	Active
Skyhawk	27-1170	FDA UDI	Class II	Active
Janus	36-2735	FDA UDI	Class II	Active
Pillar Xl	72-2415	FDA UDI	Class II	Active
Skyhawk	27-2539	FDA UDI	Class II	Active
Skyhawk	27-1279	FDA UDI	Class II	Active
Sfs	61-8310	FDA UDI	Class II	Active
Icon	54-3840	FDA UDI	Class II	Active
Forza	89-4208SP	FDA UDI	Class II	Active
Forza Xp	28-4144	FDA UDI	Class II	Active
Firebird	44-3570	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.