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Smith & Nephew, Inc. recalls Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Recalled May 2, 2018 · FDA recall Z-1536-2018 · Smith & Nephew
Hazard
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. · FDA Class II
Units
22
Sold at
Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
Description
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.
Product
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →