Z-2158-2012Class II

REF IFNT611Full OSSEOTITE Tapered Certain Implant 6 x 11.5mmSterile by radiationRx Only***BIOMET...

Name: Z-2158-2012 ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET...
Creator: Biomet 3i, LLC
Published: 2012-03-23
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2012-03-23 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1... on 2012-03-23. FDA classified it as Class II and gives the reason as "Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment...". 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-2158-2012
Classification: Class II
Status: Terminated
Initiated: 2012-03-23
Posted: 2012-08-08
Terminated: 2013-12-16
Recalling firm: ZimVie US Corp LLC
Product: ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. 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 endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: BIOMET 3i sent an Urgent Medical Device Recall letter on March 19, 2012, to all affected customers via email or fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers are to return any unopened and unused product for replacement at no cost. In addition, customers should contact Customer Service at 1-800-342-5454 for assistance if they encounter issues with the mating component, or if they have any questions or concerns. Customers are to respond to the notification regardless of whether they have product to return.
Quantity in commerce: 240
Distribution: Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong.
Product codes and lots: Lot Number 2011110798

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2158-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2158-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08

Product code NHA

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)