Z-2207-2013Class II

Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant

Name: Z-2207-2013 Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant
Creator: Biomet 3i, LLC
Published: 2013-06-10
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2013-06-10 / Terminated / root cause: design

FDA source

Biomet 3i, LLC began a recall of Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for... on 2013-06-10. FDA classified it as Class II and gives the reason as "One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2207-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-10
Posted: 2013-09-16
Terminated: 2014-11-06
Recalling firm: ZimVie US Corp LLC
Product: Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: 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: One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
Root cause tag: design
FDA root cause: Device Design
Action: Biomet 3i sent an Urgent: Medical Device Recall letter dated June 10, 2013 to affected customer via email, facsimile, or postal mail. The letter identified the affected product, problem, and actions to be taking. Customer were instructed to check their respective inventory for the affected product and return to Biomet 3i. Biomet 3i will issue replacement product. For questions or concerns call 1-800-342-5454.
Quantity in commerce: 215
Distribution: Worldwide Distribution - USA Nationwide in the states of MA, CT, NJ, DE, NY, FL, OK, TX, PA, DC, IL, KS, LA, MD, CA, RI, TN, MN, and SC and the countries of Canada, Japan, Australia, Italy Germany, France, Switzerland, Apain, Brazil, Uruguay, Singapore, Dominican Republic, Taiwan, Austria, Portugal, and the United Kingdom.
Product codes and lots: XIIOS5411

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2207-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2207-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-16
Z-2208-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-16

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