Recall Z-1629-2026 ยท OLO Orthopedic Stereotaxic Instrument
Orthalign, Inc
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
| Date | Mar 24, 2026 (initiated Feb 10, 2026) |
| Status | Open, Classified |
| 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 con |
| Quantity | 7 units |
| Distribution | US Nationwide distribution in the state of UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200892 | Harvey(R) Surgical Assistant Orthalign, Inc., Jun 18, 2020 |