Z-1630-2026Class II

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

Name: Z-1630-2026 Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Creator: Orthalign, Inc
Published: 2026-02-10
License: https://open.fda.gov/license/

OrthAlign, Inc. / initiated 2026-02-10 / Open, Classified / root cause: manufacturing process

FDA source

Orthalign, Inc began a recall of Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System on 2026-02-10. FDA classified it as Class II and gives the reason as "Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1630-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-10
Posted: 2026-03-24
Recalling firm: OrthAlign, Inc.
Product: Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 7 units
Distribution: US Nationwide distribution in the state of UT.
Product codes and lots: Lot # 25092204BB/ UDI:00810832032434

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1630-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1629-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-24
Z-1630-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-24

Product code OLO

K200892Class IIHarvey(R) Surgical AssistantOrthalign, Inc. / cleared 2020-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)