Class 2 Device Recall TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor

• Date Initiated by Firm: August 06, 2013
• Date Posted: September 17, 2013
• Recall Status: Terminated on April 20, 2016
• Recall Number: Z-2231-2013
• Recall Event ID: 66037
• 510(K)Number: K093844
• Product Classification: Fastener, fixation, biodegradable, soft tissue - Product Code MAI
• Product: TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
• Code Information: 50324715 50324960 50326833 50336719 50336768 50339643 50339651 50341854 50344396 50348650 50349838 50350841 50351449 50353295 50360151 50363875 50368586 50372045 50374017 50375716 50378770 50381624 50387868 50390937 50395330 50397700 50402973 50404638 50406692 50408058 50412954 50415137 50416799 50418989 50429269 50429640 50429642 50429832 50431134 50439753 50439754 50442740 50443625
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc. Endoscopy Division; 150 Minuteman Drive; Andover MA 01810-1031
• For Additional Information Contact: Albert A. Pytka; 978-749-1073
• Manufacturer Reason for Recall: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
• FDA Determined Cause: Packaging
• Action: Smith&Nephew sent an Urgent Product Recall Notification letter dated August 6, 2013, via Federal Express to all affected customers. Addendum customer letters for 4 additional part numbers were sent via Federal Express on August 19, 2013, The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to inspect their inventory, locate unused devices and quarantine them. Customers were also asked to complete the last three columns in the inventory Return Certification form indicating the quantities that need to be returned, and include their contact information in the spaces provided. Customers were instructed to contact Smith & Nephew's Demo Service Departmentat 800-343-5717 for a Return Authorization (RA#), and provide the information response form. Replacement product would be provided. For questions regarding this recall call 978-749-1073.
• Quantity in Commerce: 3827 US
• Distribution: Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
• 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.

• 510(K) Database: 510(K)s with Product Code = MAI