| Class 2 Device Recall Osteoraptor Suture Anchor |  |
Date Initiated by Firm | August 06, 2013 |
Date Posted | September 17, 2013 |
Recall Status1 |
Terminated 3 on April 20, 2016 |
Recall Number | Z-2227-2013 |
Recall Event ID |
66037 |
510(K)Number | K082215 |
Product Classification |
Staple, fixation, bone - Product Code JDR
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Product | OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291
Biodegradable suture anchor |
Code Information |
50366964 50366974 50366982 50366987 50366991 50370758 50370941 50370943 50371293 50376477 50387447 50392962 50394696 50397924 50400302 50400308 50408067 50414256 50415787 50417207 50419579 50425118 50428815 50429654 50431732 50435075 50435211 50444669 50445035 50445761 50445877 50450950 50458418 50458435 |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Drive Andover MA 01810-1031
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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 | 4946 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 |
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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.
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510(K) Database | 510(K)s with Product Code = JDR
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