Z-0119-2013Class II

Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical...

Name: Z-0119-2013 Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical...
Creator: Biomet 3i, LLC
Published: 2012-08-03
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2012-08-03 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a... on 2012-08-03. FDA classified it as Class II and gives the reason as "Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading". 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-0119-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-03
Posted: 2012-10-23
Terminated: 2012-12-20
Recalling firm: ZimVie US Corp LLC
Product: Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Biomet 3 i sent an Urgent Medical Device Recall letter dated August 3, 2012, to all affected customers via e-mail, facsimile, telephone, or postal mail. Each customer was instructed to check their inventory for the affected product and provide feedback to Biomet 3i. Product is to be returned to: Biomet 3i P.M. Regulatory Compliance 4555 Riverside Drive Palm Beach Gardens, Florida 33410 For questions customers were instructed to call 1-800-342-5454. For questions regarding this recall call 561-776-6700.
Quantity in commerce: 227
Distribution: Worldwide Distribution - USA including PA, GA, OR, KS, NY, VA, CT, NH, IL, OK, and MA and internationally to Australia, Brazil, Columbia, France, Germany, Ireland, Italy, Japan, Paraguay, Portugal, and Spain.
Product codes and lots: Model # INT510, Lot # 2011090751

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0119-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0119-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-23

Product code DZE

K063341Class II3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. / cleared 2007-04-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)