Events

Recall of AdeptMed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Adept-Med International 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
    35406
  • Event Risk Class
    Class 2
  • Event Number
    Z-1156-06
  • Event Initiated Date
    2004-08-17
  • Event Date Posted
    2006-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46015
  • 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
    Retainer Fish - Product Code GZC
  • Reason
    Devices for which sterility may be compromised as evidenced by a loss of package integrity.
  • Action
    On 8/13/04, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

Device

AdeptMed
  • Model / Serial
    1104, 1204, 11203, 11103, 11503, 11403, 10503
  • Product Classification
    Physical Medicine Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide-The product was released for distribution to 249 consignees in US. The firm identified 242 hospitals and 7 distributors. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, hospitals who received the recalled product.
  • Product Description
    Adept-Med brand Glassman Viscera Retainer FISH Sterile, || Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; || Product is manufactured and distributed by Adept-Med International, Inc., 665 Pleasant Valley Rd., Diamond Springs, CA 95619
  • Manufacturer
    Adept-Med International Inc

Manufacturer

Adept-Med International Inc
  • Manufacturer Address
    Adept-Med International Inc, 694 Pleasant Valley Rd Ste 4, Diamond Springs CA 95619-9249
  • Source
    USFDA