Skip to content

Lantern recallZ-1630-2026 · Orthalign, Inc · initiated Feb 10, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Orthalign, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

On February 10, 2026, OrthAlign issued a Urgent: Medical device Recall Notification via overnight mail. OrthAlign asked consignees to take the following actions: Please review your inventory for the affected products listed in Table 1. 1. Immediately remove and quarantine the affected products until the products are returned to OrthAlign. 2. Please share this recall notification with all members in your network as well as those where the affected devices have been transferred. 3. If you have further distributed the affected products, please identify and notify consignees. You may provide consignees a copy of this notification letter. 4. Please complete the attached response form within Five (5) business days and email the completed form to : [email protected] 5. Adverse actions are quality issues and can be reported to the Food and Drug Administration s MedWatch program: o Online: By completing and submitting the report online at www.fda.gov/medwatch o Regular mail or fax): download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form; then complete the form and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178.

Recall details

Recall number
Z-1630-2026
Status
Open, Classified
Initiated by the company
Feb 10, 2026
Posted by the FDA
Mar 24, 2026
Recalling firm
Orthalign, Inc
Quantity
7 units
Product code
OLO
FDA submissions
K200892
Distribution
US Nationwide distribution in the state of UT.

Product description

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

Code information (models, lots, serial numbers)

Lot # 25092204BB/ UDI:00810832032434

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K200892 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98516).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page