Class 2 Device Recall BIORAPTOR" 2.9 mm Suture Anchor

• Date Initiated by Firm: August 06, 2013
• Date Posted: September 17, 2013
• Recall Status: Terminated on April 20, 2016
• Recall Number: Z-2215-2013
• Recall Event ID: 66037
• 510(K)Number: K031685
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775; ; Biodegradable suture anchor
• Code Information: 50252371, 50252817, 50252818, 50253051, 50253556, 50254393, 50255140, 50255943, 50257230, 50257886, 50258390, 50258813, 50259145, 50259748, 50259820, 50260127, 50261934, 50263317, 50263909, 50264101, 50264417, 50264775, 50265257, 50265457, 50265935, 50266338, 50266709, 50266926, 50267287, 50267297, 50267742, 50268009, 50268284, 50268801, 50269502, 50269812, 50270227, 50270716, 50271271, 50271608, 50271908, 50272544, 50273015, 50273358, 50273640, 50273933, 50274557, 50274799, 50275368, 50276253, 50276254, 50276805, 50277029, 50277294, 50277527, 50277929, 50278456, 50278571, 50278899, 50279282, 50279628, 50279887, 50280270, 50280509, 50280951, 50281119, 50281654, 50281988, 50282538, 50282785, 50283315, 50283661, 50284261, 50284507, 50285047, 50285232, 50286292, 50286603, 50287484, 50287742, 50287951, 50288412, 50288413, 50288709, 50288711, 50289018, 50289361, 50289598, 50290037,50290863, 50291536, 50291656, 50292239, 50292240, 50292919, 50293285, 50293609, 50293897 50294168, 50294377, 50295055, 50295263 50296219 50296742 50297227 50297778 50297779 50297780 50298062 50298419 50298786 50299246 50299545 50299546 50299826 50300216 50300804 50301267 50301404 50302151 50302685 50303058 50303427 50303788 50303941 50304178 50304532 50305224 50305593 50306159 50306607 50306999 50307177 50307178 50307323 50307855 50308129 50308350 50308876 50309006 50309569 50309929 50310088 50310360 50310603 50311024 50311465 50311593 50312088 50312508 50312903 50313096 50313194 50313433 50313434 50313810 50313981 50314087 50314275 50314383 50314587 50314734 50314912 50315220 50315412 50315573 50316170 50316287 50316663 50316991 50317294 50317333 50317334 50319134 50319316 50319548 50319721 50320087 50320539 50320883 50321123 50321480 50321923 50322389 50322921 50323075 50323255 50323447 50323635 50323776 50324607 50326329 50327629 50327993 50331045 50328867 50329238 50331335 50331336 50331537 50332615 50332903 50333951 50334376 50335473 50336653 50337963 50338375 50339635 50340038 50340416 50340763 50342101 50343001 50344257 50345538 50347525 50348062 50348915 50349098 50349263 50350688 50350689 50350836 50352820 50353935 50354580 50355436 50356119 50356623 50357088 50357393 50357564 50357945 50358202 50358558 50359337 50360155 50360278 50361746 50362228 50363184 50363885 50364586 50365181 50366145 50367196 50367857 50369186 50370317 50370991 50371619 50372060 50373120 50373578 50374500 50375710 50376426 50376982 50377966 50378141 50378906 50379638 50380808 50381014 50382645 50383518 50385488 50388028 50388735 50391247 50392262 50393194 50393195 50393328 50394070 50395083 50396301 50396306 50397055 50397697 50398394 50399613 50400932 50401260 50402476 50403935 50405215 50406205 50407446 50410767 50411908 50412270 50413576 50415461 50416150 50417011 50418094 50420319 50423595 50423956 50426322 50427033 50428117 50429370 50429371 50429656 50430184 50430404 50434435 50436746 50437585 50438204 50439582 50441442 50441680 50443183 50443859 50445451 50445521 50445522 50446168 50447915 50448596 50449837 50450220 50451518 50451942 50455628 50457777 50458924 50461408
• 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: 43385 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 = HWC and Original Applicant = SMITH & NEPHEW, INC.