Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Summary
The FDA issued a Class II for Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component L by Orthalign, Inc. Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm).
Details
Source
Device Recall
External ID
Z-1629-2026
Action Date
2026-04-01
Status
Ongoing
Category
device
Product Description
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Lot/Code Info: Lot # 25091103BB/ UDI: 00810832032427
Quantity Affected: 7 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-10
Company
Aliso Viejo, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Orthalign, Inc has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Orthalign, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Orthalign, Inc have FDA actions?
Orthalign, Inc has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1629-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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