Recall Z-0529-05 ยท EKB Explorer, Operative
Hu-Friedy Mfg Co, Inc.
Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. 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 100-7409 Explorer - Single End #7 SE. +H65810074090C. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to
| Date | Feb 4, 2005 (initiated Jan 7, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 42,517 total units distributed (all date codes) |
| Distribution | Dental practitioners, hospitals, dental clinics and distributors located nationwide, in Puerto Rico and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.