Z-1409-2015Class II

3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants

Name: Z-1409-2015 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants
Creator: Biomet 3i, LLC
Published: 2014-11-07
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2014-11-07 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants on 2014-11-07. FDA classified it as Class II and gives the reason as "Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1409-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-07
Posted: 2015-04-10
Terminated: 2015-05-22
Recalling firm: ZimVie US Corp LLC
Product: 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: Biomet 3i sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 7, 3014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
Quantity in commerce: 620 implants in total
Distribution: Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.
Product codes and lots: Implant PN # BOST3211 Lot # 2014051395 Exp date 12/11/2018 and Lot # 2014051817 Exp date 12/09/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1409-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1409-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-22	2015-04-10
Z-1410-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-22	2015-04-10
Z-1411-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-22	2015-04-10

Product code DZE

K122300Class IIT3 Dental ImplantBiomet 3i / cleared 2013-01-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)