| Class 2 Device Recall Smith &38; Nephew | |
Date Initiated by Firm | June 02, 2014 |
Date Posted | July 14, 2014 |
Recall Status1 |
Terminated 3 on September 15, 2017 |
Recall Number | Z-2048-2014 |
Recall Event ID |
68565 |
510(K)Number | K122059 |
Product Classification |
Fastener, fixation, nondegradable, soft tissue - Product Code MBI
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Product | SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white)
Product Code: 72203853
Fastener, fixation, nondegradable, soft tissue |
Code Information |
Lot Numbers: 50478983, 50478986, 50478989, 50482871, 50484944, 50485587, 50485589 |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Drive Andover MA 01810-1031
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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 | 1086 untis |
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 |
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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 = MBI
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