Z-0923-03

Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant...

Name: Z-0923-03 Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant...
Creator: Implant Innovations, Inc.
Published: 2003-05-09
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2003-05-09 / Terminated

FDA source

Implant Innovations, Inc. began a recall of Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach... on 2003-05-09. The reason FDA records is "Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0923-03
Status: Terminated
Initiated: 2003-05-09
Posted: 2003-06-17
Terminated: 2012-05-03
Recalling firm: ZimVie US Corp LLC
Product: Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills.
FDA root cause: Other
Action: The firm faxed and e-mailed a recall communication to international accounts on 5/9/2003 and mailed recall letters to domestic accounts on 5/12/2003. The firms were requested to examine their stock and return product as well as to notify any subaccounts of the recall and recover and return their products. Letters to specific consignees only listed the recalled lot numbers that were shipped to that consignee. A response form was included and was to be faxed back to the recalling firm.
Quantity in commerce: 185
Distribution: Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil.
Product codes and lots: lot numbers 126509, 183758, 186315, 188528, 187918, 188867, 190033, 191429, 196769.

Product code DZE

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)