Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follow

FDA device recall Z-0386-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Implant Innovations, Inc.

Reason for recall

The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.

Action taken

The firm notified international distributors on 12/2/2003 via e-mail and also a recall notification letter was faxed to them on 12/2/2003. They were instructed to subrecall to the health professional level. Also on 12/2/2003 all domestic accounts (health practioners) were telephoned and then faxed a recall notification letter. Each account was instructed to check their inventory, respond back by fax and to return recalled product to Implant Innovations Inc.

Root cause

Other

Status

Terminated

Product code

DZI

Quantity affected

40

Distribution

Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada, Sweden, Germany, Colombia, Spain, Switzerland, Australia, Japan, Austria, Franc

Date initiated

2003-12-02

Date posted

2004-07-20

Date terminated

2009-10-05

Location

Palm Beach Gardens, FL