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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 Device Recall Osteoraptor Suture Anchorsee related information
Date Initiated by FirmAugust 06, 2013
Date PostedSeptember 17, 2013
Recall Status1 Terminated 3 on April 20, 2016
Recall NumberZ-2226-2013
Recall Event ID 66037
510(K)NumberK082215 
Product Classification Staple, fixation, bone - Product Code JDR
ProductOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor
Code Information 50272335 50272468 50274466 50274792 50275817 50278112 50282209 50283021 50286518 50286657 50286925 50288725 50290551 50291360 50294564 50295956 50296887 50298073 50301797 50307182 50309401 50309926 50310781 50312498 50314440 50319909 50320249 50322931 50323640 50325599 50326068 50329810 50329975 50333958 50335745 50338377 50341064 
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information ContactAlbert 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		Packaging
ActionSmith&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 Commerce4452 US
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = JDR
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