Class 2 Device Recall INFUSE Bone Graft X SMALL KIT

• Date Initiated by Firm: September 27, 2018
• Create Date: November 09, 2018
• Recall Status: Terminated on September 16, 2020
• Recall Number: Z-0440-2019
• Recall Event ID: 81171
• PMA Number: P000058 P050053
• Product Classification: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction - Product Code NEK
• Product: INFUSE Bone Graft X SMALL KIT REF 7510100
• Code Information: UDI 00613994239525, Lot Number M111806AAA
• FEI Number: 1000477302
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek USA Inc; 1800 Pyramid Pl; Memphis TN 38132-1703
• For Additional Information Contact: Eric Epperson; 901-344-1435
• Manufacturer Reason for Recall: The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
• FDA Determined Cause: Error in labeling
• Action: The firm initiated the recall by letter on 09/27/2018. The firm will coordinate the return of the recalled product.
• Quantity in Commerce: 138 units
• Distribution: US
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NEK