United StatesOrthalign, Inc is recalling Drill Plate, Ortho Dev. Trimax – Pegged, PREF Size 1–5 (REF 402566, Lot #25091103BB, UDI 00810832032427) and Size 6–7 (REF 402567, Lot #25092204BB, UDI 00810832032434), components of the Lantern Knee System; seven units were distributed in Utah, United States. The drill plates were manufactured out of specification and can result in a bone cut in excess 00800" (2.8448mm).
What's being recalled
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Recalling firm: Orthalign, Inc, Aliso Viejo, CA, United States.
How to identify it
Lot # 25091103BB/ UDI: 00810832032427 Lot # 25092204BB/ UDI:00810832032434
The hazard
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the state of UT.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)