FDA Medical devices recall ·
Drill Plate, Ortho Dev recall
- Recall number
- Z-1630-2026
- Date
- (initiated February 10, 2026)
- Company / brand
- Orthalign, Inc
120 Columbia Ste 500, Aliso Viejo, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7 units
- Hazard tags
- Laceration
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Why was it recalled?
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 25092204BB/ UDI:00810832032434
Distribution
US Nationwide distribution in the state of UT.
States: Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1630-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.