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Orthalign, Inc.

United States·US-MF-000027362

Last updated September 17, 2026

Information

Page 8 of 8

Device	Model / Reference	Registries	Class	Status
OrthAlign Plus	403028	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403440	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403441	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403027	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403258	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	402048	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	401582	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	401616	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403108	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403430-09	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403498	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	402043	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	401587	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403377	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403430-05	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403105	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403402	EUDAMEDFDA UDI	Class I	Active
KneeAlign 2	133631-01	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403030	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	401595	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403442	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403032	EUDAMEDFDA UDI	Class I	Active
OrthAlign Plus	403445	EUDAMEDFDA UDI	Class I	Active

Not available yet.

Not available yet.

Not available yet.

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
Feb 10, 2026	Z-1630-2026	—	open, classified	Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Feb 10, 2026	Z-1629-2026	—	open, classified	Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)