SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
FDA Recall Z-2048-2014 · Posted 2014-07-14
Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeMBI
Date Initiated2014-06-02
Date Terminated2017-09-15
Product Quantity1086 untis
Reason for Recall
Sterility of device is compromised due to breach in sterile barrier
Firm 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 [email protected]. They will provide customers with instructions for returning their product and receiving a replacement.
For questions regardin g this recall call 978-749-1073.
Root Cause
Package design/selection
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.