Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
FDA Recall #Z-1536-2018 — Class II — December 11, 2017
Product Description
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Reason for Recall
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.
Recalling Firm
Smith & Nephew, Inc. — Mansfield, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
22
Distribution
Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
Code Information
Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated