Events

Recall of Straumann Palatal Implant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Straumann 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
    45420
  • Event Risk Class
    Class 2
  • Event Number
    Z-0278-2008
  • Event Date Posted
    2007-12-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65422
  • 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
    Endosseous Orthodontic Implant - Product Code OAT
  • Reason
    Sticking transfer piece: the transfer piece which accompanies the palatal implant may get stuck during implant requiring removal by using mechanical force.
  • Action
    Straumann USA, LLC sent Urgent Device Recall letters, via FedFx on 9/28/07, requesting the return of all Straumann Palatal Implant, articles 042.335 with lot numbers 1001, FE3776, F4662, F6563, E7083, and article 042.336S lot number 1001.

Device

Straumann Palatal Implant
  • Model / Serial
    Lot Number: 1001
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - USA including states of AZ, CA, CO, ID, IL, IN, GA, KY, NH , MA, MD, MI, NM, PA, TX, UT, VA, and WA.
  • Product Description
    Straumann Palatal Implant , 4.8 L 4.2 mm, || Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008
  • Manufacturer
    Straumann USA LLC

Manufacturer

Straumann USA LLC
  • Manufacturer Address
    Straumann USA LLC, 60 Minuteman Rd, Andover MA 01810-1008
  • Source
    USFDA