Class 2 Device Recall Medtronic (Distractor Rack, REF 5598007)

• Date Initiated by Firm: November 19, 2021
• Date Posted: May 10, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1574-2023
• Recall Event ID: 92142
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
• Code Information: UDI/DI (GTIN) 00763000401535, Lot Numbers EM21D006, EM21D007; Loaner Kit Lot numbers: 0072, 0073, 0077, 0098, 0103
• FEI Number: 1000477302
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek USA Inc; 1800 Pyramid Pl; Memphis TN 38132-1703
• Manufacturer Reason for Recall: Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor.
• FDA Determined Cause: Under Investigation by firm
• Action: Medtronic issued an URGENT; Medical Device Removal notice on 11/19/2021. The notice explained the issue and the risk and requested the removal of the affected product from use pending return. It also directed the consignee to transfer the notice to other organizations which could be affected.
• Quantity in Commerce: 4 units
• Distribution: US: IN, CT, NE
• 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.