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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 5 of 171

Device	Model / Reference	Registries	Class	Status
Samba Screw	11-1109-FD7	FDA UDI	Class I	Active
Skyhawk	27-5111	FDA UDI	Class I	Active
Firebird	44-7545	FDA UDI	Class II	Active
Centurion	69-0200	FDA UDI	Class II	Active
Centurion	69-1042	FDA UDI	Class I	Active
Skyhawk	26-1006	FDA UDI	Class I	Active
Pillar Xl	72-5315	FDA UDI	Class II	Active
Skyhawk	27-2175	FDA UDI	Class II	Active
Skyhawk	27-2679	FDA UDI	Class II	Active
Skyhawk	27-1545	FDA UDI	Class II	Active
Skyhawk	27-3511	FDA UDI	Class II	Active
Skyhawk	27-4543	FDA UDI	Class II	Active
Firebird	52-6080	FDA UDI	Class II	Active
Janus	36-3755	FDA UDI	Class II	Active
Skyhawk	27-3341	FDA UDI	Class II	Active
Skyhawk	27-3319	FDA UDI	Class II	Active
Skyhawk	27-2638	FDA UDI	Class II	Active
Skyhawk	27-2117	FDA UDI	Class II	Active
Skyhawk	27-5732	FDA UDI	Class I	Active
Physio-Stim	3314LD	FDA UDI	Class II	Active
Pillar Xl	72-1312	FDA UDI	Class I	Active
Skyhawk	27-5710	FDA UDI	Class I	Active
3 Degree	60-6104	FDA UDI	Class II	Active
Firebird	52-2100	FDA UDI	Class II	Active
Skyhawk	27-4380	FDA UDI	Class II	Active
Skyhawk	27-3417	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-4755	FDA UDI	Class II	Active
Skyhawk	27-2311	FDA UDI	Class II	Active
Forza	89-0315	FDA UDI	Class I	Active
Sfs;sfs Le;sfs Scoli	55-4830	FDA UDI	Class II	Active
Construx - Mini Ptc	37-3010SP	FDA UDI	Class II	Active
Firebird	51-4455	FDA UDI	Class II	Active
Ascent Le	66-3334	FDA UDI	Class II	Active
Firebird Nxg	36-8315	FDA UDI	Class I	Active
Lonestar	84-5314	FDA UDI	Class II	Active
Skyhawk	27-4575	FDA UDI	Class II	Active
Ascent Le	66-3226	FDA UDI	Class II	Active
Pillar Xl	73-1920	FDA UDI	Class I	Active
Skyhawk	27-2272	FDA UDI	Class II	Active
Sfs;sfs Le;sfs Scoli	59-3750	FDA UDI	Class II	Active
Skyhawk	27-2608	FDA UDI	Class II	Active
Forza	89-0400	FDA UDI	Class I	Active
Skyhawk	27-2449	FDA UDI	Class II	Active
Skyhawk	27-3576	FDA UDI	Class II	Active
Fenestrated Screws	36-5530SP	FDA UDI	Class II	Active
Firebird Sfs	90-7587	FDA UDI	Class I	Active
Firebird	51-3595	FDA UDI	Class II	Active
Firebird	44-3330	FDA UDI	Class II	Active
Firebird Sfs	77-8840	FDA UDI	Class II	Active
Forza	89-1012SP	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.