CLASS II ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report
Drill Plate, Ortho Dev recalled by Orthalign
Orthalign is recalling Drill Plate, Ortho Dev, distributed nationwide in the US. The recall was initiated on 10 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1629-2026
- FDA event ID
- 98516
- Recalling firm
- Orthalign, Aliso Viejo, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Feb 2026
- FDA classified
- 24 Mar 2026
- Reported
- 1 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Hip & Knee Implants
Timeline
| 10 Feb 2026 | Recall initiated by company | |
| 24 Mar 2026 | Classified by FDA | +42 days |
| 1 Apr 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Where it was distributed
US Nationwide distribution in the state of UT.
Questions about this recall
Why was it recalled?
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Which lots are affected?
Lot # 25091103BB/ UDI: 00810832032427
Where was it sold?
US Nationwide distribution in the state of UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98516| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Drill Plate, Ortho Dev recalled by Orthalign | Orthalign | Potency & Assay | Nationwide |
More recalls from Orthalign
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Drill Plate, Ortho Dev recalled by Orthalign | Orthalign | Potency & Assay | Nationwide |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |