Z-2139-2011

REF IOSS413 OSSEIOTITE Certain Implant 4 x 13mm* Sterile using Radiation* Rx Only***BIOMET 3i...

Name: Z-2139-2011 ***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** Rx Only***BIOMET 3i...
Creator: Biomet 3i, LLC
Published: 2011-03-10
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2011-03-10 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of ***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl... on 2011-03-10. The reason FDA records is "Biomet 3i is recalling their product Osseotite Certain Implant Device IOSS413. The internal thread was not manufactured correctly". 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-2139-2011
Status: Terminated
Initiated: 2011-03-10
Posted: 2011-05-04
Terminated: 2012-01-25
Recalling firm: ZimVie US Corp LLC
Product: ***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using 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*** 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: O-FY
Reason for recall: Biomet 3i is recalling their product Osseotite Certain Implant Device IOSS413. The internal thread was not manufactured correctly.
Root cause tag: manufacturing process
FDA root cause: Other
Action: BIOMET 3i sent an Urgent Medical Device Recall Letter on March 14, 2011, to all affected customers via emial or fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told to contact Customer Service at 1-800-342-5454. Customers were instructed to respond with the attached Response Fax or email [email protected]. If customers still had implant(s) in their inventory, they were to return the implant(s) to BIOMET 3i using the following address: BIOMET 3i Regulatory Compliance Department 4555 Riverside Drive Palm Beach Gardens, Florida 33410 Incident No. CD117886 A replacement implant(s) will be sent to them one the product is returned. For questions regarding this recall call 561-776-6906 (EST 8:00am to 5:00pm).
Quantity in commerce: 217
Distribution: Worldwide Distribution - USA including AK, FL, GA, NC, NJ, NY, SC and the countries of Canada, Europe, Japan, and South America.
Product codes and lots: Lot number: 2009110838.

Product code O-FY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)