Events

Recall of Straumann Bone Level Tapered 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
    69379
  • Event Risk Class
    Class 2
  • Event Number
    Z-0117-2015
  • Event Initiated Date
    2014-09-19
  • Event Date Posted
    2014-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130365
  • 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
    Assembled with narrow connect (nc) transfer piece instead of regular connect (rc).
  • Action
    Strauman notified consignees of this Field Corrective Action by letter dated September 19, 2014 and delivered via hand by Straumann Representative. Accounts are requested to return inventory. Contact (978) 747-2514 for assistance.

Device

Straumann Bone Level Tapered Implant
  • Model / Serial
    Lot number: GY030 Exp. 2019-04
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution in states of: FL and MA.
  • Product Description
    Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim || Article Number: 021 .5308 || 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.
  • 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