Events

Recall of Device Recall Henry Schein Explorer Double End 5

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hu-Friedy Mfg Co, 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
    28672
  • Event Risk Class
    Class 2
  • Event Number
    Z-0834-04
  • Event Initiated Date
    2004-03-29
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32317
  • 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
    Explorer, Operative - Product Code EKB
  • Reason
    Reports of breakage on some dental explorers were received by the own label distributor and forwarded to hu-friedy mfg. co. (importer of record & spec. setter). investigation conducted by hu-friedy mfg. co. revealed that the tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture.
  • Action
    On 3/29/04, Hu-Friedy Mfg. Co. notified Henry Schein, Inc. of the recall by telephone. This was followed up with a letter on 4/2/04. Henry Schein initiated a sub-recall to its customers by sending recall letters and response forms (dated 3/31/04) by First Class Mail on 4/2/04 & 4/5/04. The mailing will be followed up with fax, e-mail or phone calls.

Device

Device Recall Henry Schein Explorer Double End 5
  • Model / Serial
    Date Codes/Lot Numbers: 0902, 1202, 0103 (0902 represents September 2002, 1202 represents December 2002, & 0103 represents January 2003); Product Code/Mfr. Part Code 100-8008.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The products were sold to the sole direct account: the Own Label Distributor, Henry Schein, Inc. in Melville, NY. Henry Schein further distributed the explorers to end users nationwide and internationally. Henry Schein Divisions located in Canada, Spain, France, Germany, United Kingdom, Holland, and New Zealand who further distributed the explorers to their customers in Canada and abroad.
  • Product Description
    HENRY SCHEIN(R) 100-8008 Explorer-Double End #5. Barcode *+H658100800808*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing # B057701.
  • Manufacturer
    Hu-Friedy Mfg Co, Inc.

Manufacturer

Hu-Friedy Mfg Co, Inc.
  • Manufacturer Address
    Hu-Friedy Mfg Co, Inc., 3232 N Rockwell St, Chicago IL 60618-5944
  • Source
    USFDA