FDA-Device2018-05-02Class II
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Smith & Nephew, Inc.
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.
Sold states
Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
Affected count
22
Manufactured in
130 & 120 Forbes Blvd, N/A, Mansfield, MA, United States
Products
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1536-2018Don't want to check this manually?
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