Events

Recall of Device Recall WHIPKNOT Soft Tissue Cinch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79700
  • Event Risk Class
    Class 2
  • Event Number
    Z-1536-2018
  • Event Initiated Date
    2017-12-11
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163060
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Fastener, fixation, biodegradable, soft tissue - Product Code MAI
  • Reason
    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.
  • Action
    On 12/11/2017, recall notifications were sent to Hospital Representatives, Affiliates/Distributors, and Sales Personnel. Notified consignees were instructed to inspect inventory and quarantine any affected devices, return the completed Inventory Return Certification Form, and return the affected product. In addition to the above, Affiliates and Distributors were instructed to forwarding the recall letter to customers and asking them to return any recalled product. Consignees were instructed to contact the firm via email at FieldActions@smith-nephew.com

Device

Device Recall WHIPKNOT Soft Tissue Cinch
  • Model / Serial
    Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
  • Product Description
    Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 130 & 120 Forbes Blvd, Mansfield MA 02048
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA