Class 2 Device Recall Smith and Nephew TWINFIX QUICKT

• Date Initiated by Firm: June 15, 2016
• Create Date: July 18, 2016
• Recall Status: Terminated on March 22, 2021
• Recall Number: Z-2218-2016
• Recall Event ID: 74449
• Product Classification: arthroscope accessory - Product Code NBH
• Product: Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
• Code Information: Batch numbers: 50412843, 50477278, 50527184
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 130 & 120 Forbes Blvd; Mansfield MA 02048
• For Additional Information Contact: 800-544-2330
• Manufacturer Reason for Recall: The device could be subject to breaches of its sterile packaging.
• FDA Determined Cause: Package design/selection
• Action: Urgent Recall Notification Letters were sent via Federal Express on June 15, 2016, to the customers listed in the firm's distribution report. Customers were asked to inventory their devices and contact the firm for return authorizations.
• Quantity in Commerce: 563
• Distribution: Worldwide distribution. US nationwide, AT, AU, DE, FR, GB, JP, PT, and RU.
• 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.