FDA Class II recall Z-1629-2026 targets Orthalign, Inc.'s Lantern Knee System drill plates (REF:402566). The agency determined that drill plates manufactured outside specification tolerances may produce bone cuts exceeding 0.0800 inches (2.8448mm), posing a risk of improper surgical outcomes during knee procedures. The recall is ongoing with nationwide distribution.

Healthcare providers and medical facilities should immediately quarantine and discontinue use of REF:402566 drill plates. Inventory checks should be conducted to identify affected products. Providers should contact Orthalign, Inc. directly for return authorization and replacement options. Continued use of out-of-specification drill plates during surgery may result in patient injury requiring corrective interventions.