Events

Recall of Device Recall Syneture Sofsilk

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Covidien LP.

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
    59104
  • Event Risk Class
    Class 2
  • Event Number
    Z-2815-2011
  • Event Initiated Date
    2011-06-03
  • Event Date Posted
    2011-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101166
  • 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
    Suture, nonabsorbable, silk - Product Code GAP
  • Reason
    Potential for the sterile barrier to be breached compromising the sterility of the product.
  • Action
    Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product. Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product. Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.

Device

Device Recall Syneture Sofsilk
  • Model / Serial
    Lot Code Number:  D1C0052G D1C0054G D1C0323G D1C0372G D1C0384G D1C0442G D1C0477G D1C0482G D1C0690GX D1C0691GX D1C1009GX
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Product Description
    Syneture Sofsilk 2/0 BLACK 5x18" V-20 D-TACH || non-absorbable silk sutures || GS62M || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • Manufacturer Address
    Covidien LP, 60 Middletown Ave, North Haven CT 06473-3908
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA