Events

Recall of Device Recall Straumann NC Closure Screw

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
    46358
  • Event Risk Class
    Class 3
  • Event Number
    Z-1037-2008
  • Event Initiated Date
    2008-01-10
  • Event Date Posted
    2008-04-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67277
  • 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
    Precision attachment - Product Code EGG
  • Reason
    Mislabeled package: narrow connection (nc) closure screws contain closure screws for the regular connection (rc) bone level implant. the rc closures screw is larger (3.5mm diameter) and therefore, will not fit into the nc implant (3.0mm diameter) narrow connection.
  • Action
    Consignees were notified by telephone on 1/10/08 followed by an Urgent Device Recall letter on January 10, 2008. The letter instructs users to return any affected product to the firm along with a recall acknowledgement form. For additional information, contact 978-747-2514.

Device

Device Recall Straumann NC Closure Screw
  • Model / Serial
    Lot Number: G8677
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of CA, DE, FL, IL, ME, NY, OH, OR, and TX.
  • Product Description
    Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810
  • 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