Class 2 Device Recall Osteoraptor Suture Anchor

• Date Initiated by Firm: August 06, 2013
• Date Posted: September 17, 2013
• Recall Status: Terminated on April 20, 2016
• Recall Number: Z-2228-2013
• Recall Event ID: 66037
• 510(K)Number: K082215
• Product Classification: Staple, fixation, bone - Product Code JDR
• Product: OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290; ; Biodegradable suture anchor
• Code Information: 50364854 50366872 50366972 50366980 50366985 50366989 50370760 50370771 50370940 50371292 50376475 50385813 50386237 50386563 50386749 50388066 50391012 50394695 50396184 50400301 50400306 50400307 50403488 50404241 50406445 50407524 50407571 50410789 50411371 50414977 50415258 50415670 50416148 50417206 50418093 50418993 50420658 50423443 50429652 50430190 50430402 50431731 50433933 50435319 50441441 50442649 50444415 50445034 50445760 50447482 50448060 50448722 50450469 50451783 50453148 50454104 50455627 50456912 50458608 50460242
• 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: 10296 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 = JDR and Original Applicant = SMITH & NEPHEW INC., ENDOSCOPY DIVISION