HENRY SCHEIN(R) 101-0913 Explorer #2 D/E. Barcode *+H658101091306*. Made in China. For professional use only. Instrument

FDA device recall Z-0832-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Hu-Friedy Mfg Co, Inc.

Reason for recall

Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation conducted by Hu-Friedy Mfg. Co. revealed that the tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture.

Action taken

On 3/29/04, Hu-Friedy Mfg. Co. notified Henry Schein, Inc. of the recall by telephone. This was followed up with a letter on 4/2/04. Henry Schein initiated a sub-recall to its customers by sending recall letters and response forms (dated 3/31/04) by First Class Mail on 4/2/04 & 4/5/04. The mailing will be followed up with fax, e-mail or phone calls.

Root cause

Other

Status

Terminated

Product code

EKB

Distribution

The products were sold to the sole direct account: the Own Label Distributor, Henry Schein, Inc. in Melville, NY. Henry Schein further distributed the explorers to end users nationwide and internation

Date initiated

2004-03-29

Date posted

2004-07-20

Date terminated

2012-08-02

Location

Chicago, IL