Class 2 Device Recall WECK EFX" Shield

• Date Initiated by Firm: November 16, 2016
• Create Date: December 14, 2016
• Recall Status: Terminated on December 13, 2017
• Recall Number: Z-0759-2017
• Recall Event ID: 75693
• Product Classification: Instrument, ligature passing and knot tying - Product Code HCF
• Product: Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
• Code Information: Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.
• Recalling Firm/ Manufacturer: Teleflex Medical; 2917 Weck Dr; Research Triangle Park NC 27709-0186
• For Additional Information Contact: Melissa Lewis; 610-378-0131 Ext. 60348
• Manufacturer Reason for Recall: The devices wings may become partially detached from the EFx Shield during use.
• FDA Determined Cause: Other
• Action: Consignees were notified via letter on 11/16/2016.
• Quantity in Commerce: 2265 units
• Distribution: Domestic; US Nationwide; International: Belgium, Canada.
• 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.