FDA Medical Device Recalls (openFDA)
Orthalign, Inc: Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
- Recall number
- Z-1629-2026
- Recalling firm
- Orthalign, Inc
- Product
- Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
- Status
- Open, Classified
- Initiated
- 2026-02-10
- Posted
- 2026-03-24
- Terminated
- not on file
- Reason
- Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
- 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 : 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
- 7 units
- Distribution
- US Nationwide distribution in the state of UT.
- Lot, serial or model codes
- Lot # 25091103BB/ UDI: 00810832032427
- 510(k) numbers
- ["K200892"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3007521480
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28