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U.S. Department of Health and Human Services

Class 2 Device Recall Ortho Dev. Trimax Pegged, PREF Size 1 5

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 Class 2 Device Recall Ortho Dev. Trimax Pegged, PREF Size 1 5see related information
Date Initiated by FirmFebruary 10, 2026
Date PostedMarch 24, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1629-2026
Recall Event ID 98516
510(K)NumberK200892 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductDrill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Code Information Lot # 25091103BB/ UDI: 00810832032427
FEI Number 3007521480
Recalling Firm/
Manufacturer		 Orthalign, Inc
120 Columbia Ste 500
Aliso Viejo CA 92656-4107
For Additional Information ContactKaryl D. Haskell
952-221-5343
Manufacturer Reason
for Recall		Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce7 units
DistributionUS Nationwide distribution in the state of UT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLO
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