Smith & Nephew, Inc. recalls Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
- Recall date
- December 11, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1536-2018
- FDA classification
- Class II
- Brand / firm
- Smith & Nephew, Inc.
- Sold / distributed
- Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
Why it was recalled
Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.
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 #5 Sutures. PN: 7211015
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