Z-1221-2007

Product is labeled as LTX XP Miniplant, Dental Implant, Sterile

Name: Z-1221-2007 Product is labeled as LTX XP Miniplant, Dental Implant, Sterile
Creator: Biomet 3i
Published: 2007-08-03
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2007-08-03 / Terminated / root cause: labeling and UDI

FDA source

Biomet 3i began a recall of Product is labeled as LTX XP Miniplant, Dental Implant, Sterile on 2007-08-03. The reason FDA records is "The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants". 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-1221-2007
Status: Terminated
Initiated: 2007-08-03
Posted: 2007-09-18
Terminated: 2009-09-11
Recalling firm: ZimVie US Corp LLC
Product: Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: International customers were contacted first by e-mail , then by fax letter 08/03/2007.
Quantity in commerce: 240 (120 each model / lot)
Distribution: Product was not distributed within the U.S. Product was distributed Internationally - Brazil, Argentina, Israel, Mexico, Colombia, Korea, Taiwan, Uruguay, Italy, Chile.
Product codes and lots: Model No. LTX3211 - Packaged Lot No. 606199 Model No. LTX3213 - Packaged Lot No. 606191

Product code DZE

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)