Events

Recall of Device Recall GEM 2753 Microvascular Anastomotic Coupler

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synovis Micro Companies Alliance 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
    48974
  • Event Risk Class
    Class 2
  • Event Number
    Z-2138-2008
  • Event Initiated Date
    2008-05-14
  • Event Date Posted
    2008-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72437
  • 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
    Microvascular Anastomotic Device - Product Code MVR
  • Reason
    Coupler rings may slip out of the delivery toolcaused by jaws larger than specification.
  • Action
    Urgent Recall Notification was sent via Fed Ex on May 15, 2008 to 432 hospitals. The letters were addressed to the attention of the Risk Manager. The recall notification instructed the hospital to immediately discontinue use, examine their inventory and, if found, to remove the product and quarantine it for return. A second notification was sent on July 21, 2008 to non-responding consignees.

Device

Device Recall GEM 2753 Microvascular Anastomotic Coupler
  • Model / Serial
    Lot numbers: 1808, 1894, 1907, 1923, 1953, 1954, 7139, 7211, 7354, 8998, 8999, 11591, 12364, 15244, 15280, 15281, 18824, 18912, 19294, 19413, 19954, 20263, 20689, 21345, 21515, 21560, 21977, 22556, and 23047
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada, Japan, UAE, Korea, South Africa, Australia, Taiwan, Norway, Netherlands, Sweden, Greece, Norway, Turkey, Portugal, Taiwan, Denmark, Italy, Germany, Japan, Spain, Austria, and Great Britain.
  • Product Description
    GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized || This is a microsurgical coupler used in the anastomosis of veins and arteries normally encountered in microsurgical vascular reconstructive procedures.
  • Manufacturer
    Synovis Micro Companies Alliance Inc

Manufacturer

Synovis Micro Companies Alliance Inc
  • Manufacturer Address
    Synovis Micro Companies Alliance Inc, 439 Industrial Ln, Birmingham AL 35211-4464
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA