Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue

FDA Recall Z-2047-2014 · Posted 2014-07-14

Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeMBI
Date Initiated2014-06-02
Date Terminated2017-09-15
Product Quantity907 units

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.

K122059ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORSSmith & Nephew, Inc. · 2013-03-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑