Events

Recall of Device Recall Zimmer Dental Calcitite 40602

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer 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
    50887
  • Event Risk Class
    Class 2
  • Event Number
    Z-0974-2009
  • Event Initiated Date
    2009-01-22
  • Event Date Posted
    2009-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77599
  • 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
    HYDROXYLAPATITE - Product Code LYC
  • Reason
    Fragments of the glass vial may be present in some of the packages from these lots.
  • Action
    The consignee in Japan was notified by e-mail and "Urgent: Device Recall" letter dated January 22, 2009 to stop using the product and to return it to the firm.

Device

Device Recall Zimmer Dental Calcitite 40602
  • Model / Serial
    Lots 60864773, 60879983 and 60967942.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    International Distribution including the country of Japan.
  • Product Description
    Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g each, 40-60 mesh size, sterile. Zimmer Dental, Carlsbad, CA; Item # 0003. || Device is used for filling of periodontal defects following conventional curettage and debridement. The device is also indicated for the esthetic repair of bony defects of the alveolar ridge beneath new or existing fixed prosthetic restorations.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA