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-2230-2013
• Recall Event ID: 66037
• 510(K)Number: K093844
• Product Classification: Fastener, fixation, biodegradable, soft tissue - Product Code MAI
• Product: TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624; ; Biodegradable suture anchor
• Code Information: 50324708 50325149 50326625 50336717 50337106 50339395 50339843 50341977 50344395 50348067 50349691 50350416 50352028 50353294 50354590 50356630 50358741 50360275 50362293 50363529 50368587 50371455 50374778 50376047 50379205 50382798 50385696 50387871 50388024 50390982 50392404 50395800 50400928 50403699 50405378 50408699 50410783 50415863 50417200 50418988 50429268 50429637 50429638 50429830 50430372 50431221 50438924 50439176 50439782 50440819 50442646 50442874 50446662 50447248 50448829 50449442 50449829 50450460 50451214 50452940 50453996 50456042 50456043 50456044 50456595 50458432 50458472
• 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: 6985 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 and Original Applicant = SMITH & NEPHEW, INC.