Events

Recall of Device Recall Straumann TSleeve

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Straumann Manufacturing 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
    52231
  • Event Risk Class
    Class 3
  • Event Number
    Z-0320-2011
  • Event Initiated Date
    2009-06-04
  • Event Date Posted
    2010-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82576
  • 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
    Incorrect inner diameter of the t-sleeve.
  • Action
    Strauman USA LLC notified the consignee by telephone on June 4, 2009, and sent an Urgent Device Recall letter dated, June 8, 2009 as a follow-up. The letter described the product, the problem, and the action to be taken by the customer. The customer was asked to return any affected product, in the prepaid preprinted mailer pouch as soon as possible to: T-sleeve Recall, Straumann USA, LLC 60 Minuteman Road Andover, MA, 01810 Customers were asked to sign and indicate on the Recall Acknowledgement Form if they would like a replacement product or a credit to their account for the product returned and fax the form to (978) 747-0023. For any questions regarding this recall call (978) 747-2575.

Device

Device Recall Straumann TSleeve
  • Model / Serial
    Lot# R9483
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Canada
  • Product Description
    Straumann T-Sleeve 2.8mm, height 6mm, guided || Article Number: 034.055V46 || Intended for use as a drilling guide to prepare a site for placement of a dental implant into the dental implant site.
  • Manufacturer
    Straumann Manufacturing Inc.

Manufacturer

Straumann Manufacturing Inc.
  • Manufacturer Address
    Straumann Manufacturing Inc., 60 Minuteman Rd, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Straumann Holding AG
  • Source
    USFDA