Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DDK315 LOT Disposable Drill Kit with DT315 STERILE
FDA Recall Z-0384-04 · Posted 2004-07-20
Recalling FirmImplant Innovations, Inc.
Recall StatusTerminated
Product CodeDZI
Date Initiated2003-12-02
Date Terminated2009-10-05
Product Quantity200
Reason for Recall
The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.
Firm Action
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
Distribution Pattern
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, France, Poland, England and Greece.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.