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U.S. Department of Health and Human Services

Class 2 Device Recall Smith &38; Nephew

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  Class 2 Device Recall Smith &38; Nephew see related information
Date Initiated by Firm June 02, 2014
Date Posted July 14, 2014
Recall Status1 Terminated 3 on September 15, 2017
Recall Number Z-2046-2014
Recall Event ID 68565
510(K)Number K122059  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture
Product Code: 72203842

Fastener, fixation, nondegradable, soft tissue
Code Information Lot Numbers: 50477397, 50481448
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact
978-749-1073
Manufacturer Reason
for Recall		 Sterility of device is compromised due to breach in sterile barrier
FDA Determined
Cause 2		 Package design/selection
Action Smith & Nephew issued an Urgent - Product Recall Notification letter dated June 2, 2014 via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and locate all affected product and quarantine them immediately. Complete the Return Certification Form . Contact the Smith & Nephew Returns Group at 800-343-5717 (option 3) or send an email to ProductRecoverv@smith-nephew.com. They will provide customers with instructions for returning their product and receiving a replacement. For questions regardin g this recall call 978-749-1073.
Quantity in Commerce 136 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
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 = MBI and Original Applicant = SMITH & NEPHEW, INC.
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