Events

Recall of Device Recall Straumann Standard Plus 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
    61440
  • Event Risk Class
    Class 2
  • Event Number
    Z-1351-2012
  • Event Initiated Date
    2012-03-12
  • Event Date Posted
    2012-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108077
  • 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
    Accessories, implant, dental endosseous - Product Code NDP
  • Reason
    Mislabeled: vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 sp 10 rn instead of 04.8 sp 10 wn.
  • Action
    Straumann sent a "FIELD CORRECTIVE ACTION NOTICE" dated March 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. Additionally, a Customer Confirmation Form was enclosed for customers to complete and return. Contact the firm at 978-747-2514 for questions regarding this notice.

Device

Device Recall Straumann Standard Plus Implant
  • Model / Serial
    Lot No. CW642
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Straumann Standard Plus Implant 04.8mm Wide Neck || SLA 10mm || Article Number: 043.652S. || Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
  • Manufacturer
    Straumann USA, LLC

Manufacturer

Straumann USA, LLC
  • Manufacturer Address
    Straumann USA, LLC, 60 Minuteman Rd, Andover MA 01810-1008
  • Manufacturer Parent Company (2017)
    Straumann Holding AG
  • Source
    USFDA