Dental Explorer D/E #5, Mfr. Part Code/Product Code 100-8008, distributed under the Henry Schein label. Classification N
FDA device recall Z-0528-05 · 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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.