Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. Distributed under the Henry Schein label. Classific

FDA device recall Z-0529-05 · posted 2005-02-04 · Terminated

Recall details

Recalling firm

Hu-Friedy Mfg Co, Inc.

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.

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.

Root cause

Other

Status

Terminated

Product code

EKB

Quantity affected

42,517 total units distributed (all date codes)

Distribution

Dental practitioners, hospitals, dental clinics and distributors located nationwide, in Puerto Rico and internationally.

Date initiated

2005-01-07

Date posted

2005-02-04

Date terminated

2012-05-24

Location

Chicago, IL