Orthalign, Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee SystemClass IIFeb 10, 2026Drill plates manufactured out of specification can result in	Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)	Class IIDevices	Feb 10, 2026
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee SystemClass IIFeb 10, 2026Drill plates manufactured out of specification can result in	Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)	Class IIDevices	Feb 10, 2026