Alphatec Spine recalled 15 units of Lateral Navigation Disc Prep Instruments on January 2, 2026, due to a design flaw. The navigated array connection geometry is incorrect, posing risks during surgical procedures. Healthcare providers and patients should stop using the instruments 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 are designed for use in surgical procedures, often utilized in spine surgeries. These instruments can be either single-use or re-usable, and are intended to be used with surgical navigation systems.
The design flaw in the navigated array connection geometry can lead to improper alignment or malfunction during surgery, increasing the risk of surgical errors.
This recall is not part of a broader industry pattern.
Consumers using these instruments may face serious risks during surgical procedures. Immediate action is necessary to prevent potential complications.
The model number and UDI-DI code can typically be found on the packaging of the instruments or the instruments themselves.
Expect a processing timeline of 4-6 weeks for refunds or replacements.
Keep records of purchase, correspondence with the manufacturer, and any relevant photographs of the instruments.
The recalled instruments include the ATEC Lateral Navigation Disc Prep Instruments, REF 267-01-000-10-N. They are intended for surgical procedures and can be non-sterile or sterile packaged. The instruments were distributed nationwide in various states including AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
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