Z-1828-2012Class II

Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part...

Name: Z-1828-2012 Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part...
Creator: Biomet 3i, LLC
Published: 2011-11-04
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2011-11-04 / Terminated / root cause: design

FDA source

Biomet 3i, LLC began a recall of Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT***... on 2011-11-04. FDA classified it as Class II and gives the reason as "On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread". 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-1828-2012
Classification: Class II
Status: Terminated
Initiated: 2011-11-04
Posted: 2012-06-20
Terminated: 2012-06-25
Recalling firm: ZimVie US Corp LLC
Product: Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing without prescription***do not use if package is damaged***do not reuse***consult instructions for use***Sterile unless package is opened or damaged.*** Product Usage: The BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means of 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: On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.
Root cause tag: design
FDA root cause: Device Design
Action: Biomet 3i sent an Urgent: Medical Device Recall letter dated November 04, 2011 via e-mail, facsimile, telephone or postal mail to all consignees affected. The letter identified the affected product, problem and actions to be taken. Each customer was instructed to check their respective inventory for the affected product and return any unused item(s) to Biomet 3i for prompt replacement. For question or concerns contact Biomet 3i at 1-800-342-5454.
Quantity in commerce: 219 units in total
Distribution: Worldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK.
Product codes and lots: Lot #2010111529

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1828-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1828-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19

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)