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Recall Observatory FDA recall evidence

Device product

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

Z-1630-2026

February 10, 2026

Class II

Product summary

Firm
Orthalign, Inc
Event
Event 98516
Status
Ongoing
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-1630-2026

Official wording

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

Code information: Lot # 25092204BB/ UDI:00810832032434

Distribution pattern: US Nationwide distribution in the state of UT.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification