Class 2 Device Recall Catalyft" LS Expandable Interbody System Anterior Standalone Cage

• Date Initiated by Firm: June 06, 2023
• Date Posted: July 10, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2118-2023
• Recall Event ID: 92567
• 510(K)Number: K212653
• Product Classification: Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
• Product: Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
• Code Information: UDI/DI 00763000465872, Lot Numbers: NM21J004, NM22A032
• FEI Number: 1000477302
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek USA Inc; 1800 Pyramid Pl; Memphis TN 38132-1703
• Manufacturer Reason for Recall: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
• FDA Determined Cause: Under Investigation by firm
• Action: Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 06/06/2023 by UPS 2-day delivery. The notice explained the problem , risk, and requested the following actions be taken: "" For purchased inventory not consumed during a procedure: o Identify and quarantine any unused impacted product(s). Refer to the table above for impacted products. o Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. " For Medtronic owned product at your facility: o Your Medtronic Sales Representative will locate and return this product. " Complete the Customer Confirmation Form enclosed with this letter (even if you have no product to return), acknowledging that you have received this information. " This notice should be distributed to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records."
• Quantity in Commerce: 8 units
• Distribution: US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OVD