Events

Recall of Device Recall Nobel Replace Tapered Groovy RP 4.3x10mm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nobel Biocare USA LLC.

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
    48702
  • Event Risk Class
    Class 3
  • Event Number
    Z-2240-2008
  • Event Initiated Date
    2007-11-02
  • Event Date Posted
    2008-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71930
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Reason
    This recall was initiated after it was discovered that the nobelreplace tapered groovy rp 4.3x10mm, ref 32216 lot#403504 has an incorrect cap label. the affected lot has a cap label identifying the implant as "4.3x8". since this cap label may be the only means used for identifying the implant prior to surgery, it is possible that a user would try to use the 10mm implant as an 8mm implant.
  • Action
    The recall was initiated on 11/02/2007 with telephone calls to the affected customers. A "Urgent Medical Device Recall" letter with attached Customer Response form was then sent via US Postal Service beginning on 11/02/2007. The letter instructed customers to please immediately remove and return REF 32216 Lot #403504, NobelReplace Tapered Groovy RP 4.3x10mm. The firm contracted UPS courier service to pick up the recalled products. Customers were also instructed if the have further distributed the affected product to please immediately notify those customer to cease using this particular lot and forward the customer this notice. The firm indicated in the recall notice that they are in the process of sending out replacement products. Contact Kam Leung at 714-282-4800 if you have questions.

Device

Device Recall Nobel Replace Tapered Groovy RP 4.3x10mm
  • Model / Serial
    Ref 32216 lot number: 403504
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AR, AZ, CA, CO, FL, GA, IA, IL, MA, ME, MI, MO, NC, NC, NJ, NY, OK, PA, TX, UT, VA, WA
  • Product Description
    NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices.
  • Manufacturer
    Nobel Biocare USA LLC

Manufacturer

Nobel Biocare USA LLC
  • Manufacturer Address
    Nobel Biocare USA LLC, 22715 Savi Ranch Pkwy, Yorba Linda CA 92887-4609
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA