Z-0297-2013Class II

Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product...

Name: Z-0297-2013 Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product...
Creator: Biomet 3i, LLC
Published: 2012-09-28
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2012-09-28 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means for prosthetic... on 2012-09-28. FDA classified it as Class II and gives the reason as "Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This...". 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-0297-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-28
Posted: 2012-11-16
Terminated: 2015-08-06
Recalling firm: ZimVie US Corp LLC
Product: Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides 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 Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Biomet 3i sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 28, 2012. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-342-5454 for questions regarding this notice.
Quantity in commerce: 191 devices
Distribution: Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, and France.
Product codes and lots: Model Number XIFNT413, Lot # 2012040462

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0297-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0297-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0298-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16

Product code DZE

K100724Class IIOsseotite II Model XifossxxxBiomet 3i, Inc. / cleared 2011-04-01

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)