Events

Recall of Device Recall Bondek Sutures

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

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
    38220
  • Event Risk Class
    Class 2
  • Event Number
    Z-1012-2007
  • Event Initiated Date
    2007-06-06
  • Event Date Posted
    2007-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53173
  • 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 - Product Code GAM
  • Reason
    The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
  • Action
    Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.

Device

Device Recall Bondek Sutures
  • Model / Serial
    Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Lot numbers: 3244075;  Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Lot #2361002; Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Lot #2401863 & 2498856;  Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136, Lot #2443985 & 3080258;  Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Lot #2528539, & 3163971;  Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G, Lot #2554480.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
  • Product Description
    Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G
  • Manufacturer
    Teleflex Creek Dr

Manufacturer

Teleflex Creek Dr
  • Manufacturer Address
    Teleflex Creek Dr, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Source
    USFDA