Orthalign recalled 7 drill plates used with its Lantern Knee System distributed nationwide, including Utah. The parts were manufactured out of specification and can cause a bone cut up to 0.008 inch (2.8448 mm). Healthcare providers were notified by letter and instructions to stop using the devices.
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthalign, Inc or your healthcare provider for instructions. Notification method: Letter
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Pegged drill plates are surgical implants used with knee replacement systems to guide drilling into bone. They are intended to ensure precise placement during procedures.
If manufactured out of specification, the drill plate can cause excess bone removal up to 0.008 inches (2.8448 mm), increasing risk of complications during knee surgery.
This recall is not described as part of a broader industry pattern.
The recall requires immediate action by healthcare providers to stop using the affected plates and consult Orthalign for next steps.
FDA enforcement page for recall Z-1629-2026; Orthalign instructions to contact for guidance
Not specified in recall notice
Keep copies of recall notice, lot numbers, and correspondence with Orthalign and your surgeon; record patient outcomes and any corrective actions
Lot # 25091103BB; UDI: 00810832032427 Manufacturer: Orthalign, Inc. Distribution: US nationwide, including Utah Quantity: 7 units Sold through: Healthcare providers (not retail consumer channels)
No injuries or incidents have been reported.
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