Dental Explorer #23 S/E, Mfr. Part Code/Product Code 100-3620, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN 100-3620 Explorer-Single End #23 SE. +H658100362003. 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).
This recall has been terminated (originally issued February 4, 2005).
- Company
- Hu-Friedy Mfg Co, Inc.
- Recall Initiated
- January 7, 2005
- Posted
- February 4, 2005
- Terminated
- May 24, 2012
- Recall Number
- Z-0527-05
- Quantity
- 42,517 total units distributed (all date codes)
- Firm Location
- Chicago, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers.
Distribution
Dental practitioners, hospitals, dental clinics and distributors located nationwide, in Puerto Rico and internationally.
Lot / Code Info
Date Codes/Lot Numbers: 0503, 0603, 0903, 1003, 1103, 1203. Barcode +H658100362003.
Root Cause
Other
Action Taken
Hu-Friedy Mfg. Co., Inc. notified the Own Label Distributor of the recall on 1/7/05 by phone, and in writing on 1/10/05. Henry Schein, Inc. is having formal "URGENT: DEVICE RECALL" letters printed up which will be mailed to over 8100 of Schein's direct customers by First Class Mail on/about 1/21/05 to initiate the sub-recall of the dental explorers. Henry Schein will follow-up to non-responders by phone and/or fax.