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U.S. Department of Health and Human Services

Class 2 Device Recall TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor

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  Class 2 Device Recall TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor see related information
Date Initiated by Firm August 06, 2013
Date Posted September 17, 2013
Recall Status1 Terminated 3 on April 20, 2016
Recall Number Z-2233-2013
Recall Event ID 66037
510(K)Number K093844  
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Product TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602

Biodegradable suture anchor
Code Information 50324714 50324959 50325405 50336718 50336766 50337107 50337110 50339396 50339650 50339654 50339835 50340055 50341065 50341288 50341608 50341852 50341974 50343277 50344392 50345531 50346096 50349836 50350192 50351792 50355983 50356629 50357082 50358377 50358556 50359999 50360659 50361740 50362632 50363174 50363872 50366312 50367556 50368583 50369516 50370078 50370505 50371296 50371908 50372043 50372901 50373581 50376024 50376595 50377415 50378045 50378652 50379636 50379935 50381013 50381052 50382145 50383363 50384738 50384957 50385695 50388023 50388427 50388915 50390006 50390936 50391241 50391607 50392270 50392402 50394175 50394700 50395079 50395329 50395678 50396196 50397457 50399965 50400926 50401256 50402972 50403490 50404762 50405432 50405695 50406373 50406776 50407574 50410247 50410909 50411608 50413138 50413770 50414757 50415220 50415662 50416307 50416797 50417199 50417996 50420510 50421494 50421722 50429267 50429347 50429634 50429635 50430369 50433008 50433009 50433120 50433338 50438321 50438322 50438923 50438981 50438982 50440714 50441083 50444410 50446345 50446447 50446997 50448199 50449437 50449827 50450459 50450942 50451511 50451937 50456336 50457052 50457924 50458755 50459278 50459634 50459731 50462225 50467497 
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 7148 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 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) Database 510(K)s with Product Code = MAI and Original Applicant = SMITH & NEPHEW, INC.
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