Class 2 Device Recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM

• Date Initiated by Firm: March 15, 2017
• Create Date: April 18, 2017
• Recall Status: Terminated on July 10, 2018
• Recall Number: Z-1840-2017
• Recall Event ID: 76824
• Product Classification: Bit, surgical - Product Code GFG
• Product: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
• Code Information: Batch Numbers: G10785, G10787, G18816, G18817
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 130 & 120 Forbes Blvd; Mansfield MA 02048
• For Additional Information Contact: SAME; 508-261-3600
• Manufacturer Reason for Recall: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
• FDA Determined Cause: Device Design
• Action: Smith &n Nephew sent an Urgent Medical Device Recall Notice dated March 15, 2017, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return product and to follow instructions on the attached Response Form. Customers with questions were instructed to email FieldActions@smith-nephew.com. For questions regarding this recall call 508-261-3600.
• Distribution: Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
• 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.