Events

Recall of Device Recall Sutures, Nonabsorbable, Silk, Sterile

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

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
    67733
  • Event Risk Class
    Class 2
  • Event Number
    Z-1296-2014
  • Event Initiated Date
    2014-03-11
  • Event Date Posted
    2014-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126185
  • 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, synthetic, polyethylene - Product Code GAT
  • Reason
    The products are being recalled because they did not meet minimum needle attachment strength requirements.
  • Action
    Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990

Device

Device Recall Sutures, Nonabsorbable, Silk, Sterile
  • Model / Serial
    Product Code: X-6371M5, Lot numbers: 02E0801603
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
  • Product Description
    Sutures, Non-absorbable, Silk, Sterile, Rx only, || Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA