Z-0665-03

LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile

Name: Z-0665-03 LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile
Creator: Implant Innovations, Inc.
Published: 2003-01-28
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2003-01-28 / Terminated / root cause: labeling and UDI

FDA source

Implant Innovations, Inc. began a recall of LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile on 2003-01-28. The reason FDA records is "Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0665-03
Status: Terminated
Initiated: 2003-01-28
Posted: 2003-03-20
Terminated: 2012-05-03
Recalling firm: ZimVie US Corp LLC
Product: LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile,
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm faxed a recall notification to their accounts on 1/28/2003. Consignees were requested to subrecall to the user/health professional level and respond. Also they were requested to provide disposition information.
Quantity in commerce: 68
Distribution: Product was distributed to four international distributor accounts only in Brasil, Korea, Taiwan and Chile.
Product codes and lots: For LTX 611 lot number 150102P For LTX 515 lot number 150100P

Product code DZE

K950204Class II3I Standard Threaded/self-Tapping Threaded Implants, Miniplants (Tm)Implant Innovations, Inc. / cleared 1995-09-27

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)