Smith & Nephew, Inc. recalls Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
- Recall date
- July 19, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2745-2016
- FDA classification
- Class II
- Brand / firm
- Smith & Nephew, Inc.
- Sold / distributed
- 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.
Why it was recalled
Sterility compromised due to breach in sterile packaging
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
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