FDA recall Z-1630-2026

Orthalign, Inc · Class II · device

Product

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System

Reason for recall

Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

Distribution

US Nationwide distribution in the state of UT.

Key facts

Status
Ongoing
Initiation date
2026-02-10
Report date
2026-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aliso Viejo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1630-2026