Z-0832-04

HENRY SCHEIN(R) 101-0913 Explorer #2 D/E. Barcode +H658101091306. Made in China. For professional use only...

Name: Z-0832-04 HENRY SCHEIN(R) 101-0913 Explorer #2 D/E. Barcode *+H658101091306*. Made in China. For professional use only...
Creator: Hu-Friedy Mfg Co, Inc.
Published: 2004-03-29
License: https://open.fda.gov/license/

HU-Friedy Mfg. Co. LLC / initiated 2004-03-29 / Terminated / root cause: labeling and UDI

FDA source

Hu-Friedy Mfg Co, Inc. began a recall of HENRY SCHEIN(R) 101-0913 Explorer #2 D/E. Barcode *+H658101091306*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior... on 2004-03-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0832-04
Status: Terminated
Initiated: 2004-03-29
Posted: 2004-07-20
Terminated: 2012-08-02
Recalling firm: HU-Friedy Mfg. Co. LLC
Product: HENRY SCHEIN(R) 101-0913 Explorer #2 D/E. Barcode *+H658101091306*. 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.
Product code: EKB Explorer, Operative
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
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 codes and lots: Date Codes/Lot Numbers: 1102, 0103 (1102 represents November 2002, & 0103 represents January 2003); Product Code/Mfr. Part Code 101-0913.

Product code EKB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)