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U.S. Department of Health and Human Services

Class 2 Device Recall Henry Schein Explorer Single End 23

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 Class 2 Device Recall Henry Schein Explorer Single End 23see related information
Date Initiated by FirmJanuary 07, 2005
Date PostedFebruary 04, 2005
Recall Status1 Terminated 3 on May 24, 2012
Recall NumberZ-0527-05
Recall Event ID 30882
Product Classification Explorer, Operative - Product Code EKB
ProductDental 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).
Code Information Date Codes/Lot Numbers: 0503, 0603, 0903, 1003, 1103, 1203. Barcode +H658100362003.
FEI Number 1416605
Recalling Firm/
Manufacturer		 Hu-Friedy Mfg Co, Inc.
3232 N Rockwell St
Chicago IL 60618-5944
For Additional Information ContactMr. Craig Schiavo
631-390-8000 Ext. 6413
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionHu-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.
Quantity in Commerce42,517 total units distributed (all date codes)
DistributionDental practitioners, hospitals, dental clinics and distributors located nationwide, in Puerto Rico and internationally.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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