Events

Recall of Device Recall Straumann Bone Level Implant

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
    74799
  • Event Risk Class
    Class 2
  • Event Number
    Z-2535-2016
  • Event Initiated Date
    2016-07-14
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148477
  • 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
    Misalignment with the loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration.
  • Action
    Straumann notified customers via telephone on Thursday, July 14, 2016. Customers with an e-mail address on file were also e-mailed on Friday, July 15, 2016.Straumann notified customers were sent a hard copy letter via UPS on Saturday, July 16, 2016 for delivery on Monday, July 18, 2016. The customers have been notified not to use these implants and to return unused implants to Straumann. The customers that have used the implants have been asked to provide the restorative situation for the implants. Depending on the restorative situation, additional instructions may be necessary to restore the implants.

Device

Device Recall Straumann Bone Level Implant
  • Model / Serial
    Lot Number: LT123
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP || Article Number: 021.4512
  • Manufacturer
    Straumann Manufacturing, Inc.

Manufacturer

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