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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 Anchor see related information
Date Posted September 17, 2013
Recall Status1 Terminated on April 20, 2016
Recall Number Z-2226-2013
Recall Event ID 66037
510(K)Number K082215 
Product Classification Staple, fixation, bone - Product Code JDR
Product OSTEORAPTOR 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 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
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 4452 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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