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U.S. Department of Health and Human Services

Class 2 Device Recall Osteoraptor Suture Anchor

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 Class 2 Recall
Osteoraptor Suture Anchor
see related information
Date Posted September 17, 2013
Recall Status1 Open
Recall Number Z-2223-2013
Recall Event ID 66037
Premarket Notification
510(K) Number
K082215 
Product Classification Staple, Fixation, Bone - Product Code JDR
Product OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
Code Information 50272332 50272462 50272750 50274144 50274350 50277105 50278907 50281510 50282171 50282827 50283849 50284637 50285830 50286658 50287767 50289371 50290043 50291934 50292091 50295383 50296070 50297228 50297782 50298793 50300135 50301932 50306856 50307462 50308037 50309210 50310436 50310780 50312090 50313439 50313818 50314915 50315807 50316601 50316986 50317483 50318001 50318687 50319907 50320679 50321916 50322244 50323257 50323630 50323780 50324608 50325611 50326067 50327821 50329242 50331546 50332253 50333092 50334400 50335620 50336405 50338241 50339832 50341062 50341605 50343271 50344262 50344618 50346215 50347305 50349093 50350513 50350978 50352032 50352701 50352997 50353606 50355123 50355672 50356987 50357104 50358206 50359714 50360454 50360914 50361413 50362647 50363190 50364588 50364909 50364915 50370316 50370385 50372675 50372728 50372892 50374025 50374503 50375408 50376044 50376238 50377316 50378706 50380530 50381197 50382647 50384163 50384950 50385362 50387220 50387886 50387896 50388742 50390996 50391608 50392266 50394701 50395538 50397273 50398231 50399415 50400574 50401262 50401918 50402459 50402823 50403367 50403718 50404238 50404920 50405868 50405869 50410769 50412026 50412957 50414254 50416317 50416526 50417204 50418001 50418331 50418992 50421031 50422577 50423435 50423591 50426460 50426933 50427032 50428116 50428624 50429271 50429999 50430000 50430400 50430503 50430504 50430505 50430657 50431379 50433038 50433039 50433040 50433041 50433127 50434653 50435732 50435733 50435734 50435809 50436890 50438659 50440452 50441439 50450277 50450752 50451781 50452210 50452585 50453453 50454295 50454418 50455195 50455483 50455813 50456909 50457385 50458416 50458475 50459739 50460097 50460240 50461060 50462482 50463458 50464108
Recalling Firm/
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover, Massachusetts 01810-1031
Consumer Instructions Contact the recalling firm for information
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 2
PRODUCTION CONTROLS: 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 18919
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JDR and Original Applicant = SMITH & NEPHEW INC., ENDOSCOPY DIVISION
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