Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

FDA device recall Z-1629-2026 · posted 2026-03-24 · Open, Classified

Recall details

Recalling firm

Orthalign, Inc

Reason for recall

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

Action taken

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 : oaregulatory@orthalign.com 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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

OLO

Quantity affected

7 units

Distribution

US Nationwide distribution in the state of UT.

Date initiated

2026-02-10

Date posted

2026-03-24

Location

Aliso Viejo, CA

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