Devices

Device Recall Henry Schein Explorer Single End 23

Model / Serial
Date Codes/Lot Numbers: 0503, 0603, 0903, 1003, 1103, 1203. Barcode +H658100362003.
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Dental practitioners, hospitals, dental clinics and distributors located nationwide, in Puerto Rico and internationally.
Product Description
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).
Manufacturer
Hu-Friedy Mfg Co, Inc.
1 Event
- Recall of Device Recall Henry Schein Explorer Single End 23

Manufacturer

Hu-Friedy Mfg Co, Inc.

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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