Events

Recall of Device Recall Straumann

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Straumann Company.

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
    29271
  • Event Risk Class
    Class 3
  • Event Number
    Z-1035-04
  • Event Initiated Date
    2004-05-21
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33441
  • 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
    Outside label incorrectly identifies drill as wide neck (wn) instead of regular neck (rn).
  • Action
    Straumann notifed conisignees by letter on May 21,2004 via Fed''X overnight advising of the error on the label states WN instead of RN. The user is advised to that the ID on the article is incorrect.

Device

Device Recall Straumann
  • Model / Serial
    Lot: 1215
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. AL, AZ, CA, DE, FL, IA, MA, MI. MD, NC, NE, NY, NJ, TX
  • Product Description
    Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel || Article No. 044.088
  • Manufacturer
    The Straumann Company

Manufacturer

The Straumann Company
  • Manufacturer Address
    The Straumann Company, 1601 Trapelo Rd, Waltham MA 02451-7333
  • Source
    USFDA