Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
FDA Recall Z-2745-2016 · Posted None
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Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeMAI
Date Initiated2016-07-19
Date Terminated2018-07-10
Product Quantity34,065 units
Reason for Recall
Sterility compromised due to breach in sterile packaging
Firm Action
Smith & Nephew issued recall letters via Federal Express on July 19, 2016 to the customers. Customers asked to inspect inventory and locate any unused devices, and quarantine immediately. Contact Smith & Nephews Field Actions Department via email at [email protected] or fax +1-901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return.
Root Cause
Package design/selection
Distribution Pattern
Worldwide distribution. US nationwide, and the countries of: AU, AT, BE, CA, CH, CR, DB, DE, ES, FI, FR, GB, GR, IC, IL, IN, IT, MY, NL, NO, PL, PR, PT,SE, SG, TH, and ZA.
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.
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