Alphatec Spine recalled 7 units of Lateral Navigation Disc Prep Instruments on January 2, 2026, due to a design flaw. The incorrect navigated array connection geometry poses a high hazard risk in surgical settings. Healthcare providers and patients must stop using the devices immediately.
Due a design issue where the navigated array connection geometry is incorrect.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Alphatec Spine, Inc. or your healthcare provider for instructions. Notification method: Letter
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The ATEC Lateral Navigation Disc Prep Instruments assist in surgical procedures by providing navigation support. Surgeons rely on these devices for accurate placements during surgery, making their reliability critical.
The design issue with the navigated array connection geometry can result in misalignment during surgical procedures, potentially leading to severe consequences for patients.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face immediate safety concerns due to the risk associated with the affected instruments. The recall may disrupt scheduled surgical procedures.
The model number and UDI-DI code can typically be found on the packaging or the device itself.
Expect a refund or replacement processing time of approximately 4-6 weeks.
Keep copies of all relevant correspondence, receipts, and any communications regarding the recall.
The recalled product is the ATEC Lateral Navigation Disc Prep Instruments, specifically the LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N. These instruments are designed for surgical procedures and may be sterile or non-sterile. They were distributed nationwide in the U.S. states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
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