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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-2224-2013
Recall Event ID 66037
Premarket Notification
510(K) Number
K082215 
Product Classification Staple, Fixation, Bone - Product Code JDR
Product OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
Code Information 50261490 50270751 50270752 50272328 50272465 50274463 50275816 50277797 50281885 50282824 50284636 50286043 50289368 50294562 50295821 50299025 50302162 50307324 50309971 50315070 50316291 50318787 50321649 50323781 50326576 50327051 50328246 50329605 50330164 50330433 50333202 50333957 50334241 50335882 50338130 50338996 50340050 50340627 50342110 50344240 50347147 50348649 50349265 50352033 50352702 50354093 50355668 50356988 50358386 50358575 50360455 50361180 50364371 50364916 50364917 50367984 50370095 50370386 50372674 50372726 50372891 50374024 50375338 50375718 50381375 50385219 50385825 50387844 50388265 50389117 50389773 50390998 50392274 50392409 50397270 50398235 50399412 50399967 50400564 50401261 50401755 50402841 50403705 50405380 50406766 50407937 50408210 50408987 50412272 50412887 50415149 50415668 50416533 50417385 50418091 50419236 50421032 50423918 50429649 50430508 50431561 50435318 50436414 50437095 50437757 50438661 50439575 50441219 50442379 50444209 50445033 50445549 50445550 50446028 50447137 50448059 50448721 50449649 50449999 50450468 50450949 50452587 50453337 50454420 50455626 50456613 50457636 50458477 50458757
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 6373 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 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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