| Class 2 Device Recall TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA 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-2232-2013 |
Recall Event ID |
66037 |
510(K)Number | K093844 |
Product Classification |
Fastener, fixation, biodegradable, soft tissue - Product Code MAI
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Product | TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631
Biodegradable suture anchor |
Code Information |
50325165 50326838 50336722 50339646 50339844 50343443 50350417 50352981 50379206 50397701 50429644 |
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 | 708 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 = MAI
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