Z-0385-04

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

Name: Z-0385-04 Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is...
Creator: Implant Innovations, Inc.
Published: 2003-12-02
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2003-12-02 / Terminated / root cause: packaging

FDA source

Implant Innovations, Inc. began a recall of 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... on 2003-12-02. The reason FDA records is "The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0385-04
Status: Terminated
Initiated: 2003-12-02
Posted: 2004-07-20
Terminated: 2009-10-05
Recalling firm: ZimVie US Corp LLC
Product: 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 DT220 2.3mm (D) x 20.0 mm (L) STERILE.
Product code: DZI Drill, Bone, Powered
Reason for recall: The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.
Root cause tag: packaging
FDA root cause: Other
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.
Quantity in commerce: 16
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, France, Poland, England and Greece.
Product codes and lots: 219636

Product code DZI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)