Z-0171-2012

REF IOSS511OSSEOTITE Certain Implant 5 x 11.5mmLOT 910695Sterile using Radiation***Rx...

Name: Z-0171-2012 ***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx...
Creator: Biomet 3i, LLC
Published: 2010-11-18
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2010-11-18 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of ***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1... on 2010-11-18. The reason FDA records is "The product may contain a manufacturing defect, that if present, may prevent the driver; cover screw or abutment from fully engaging the implant". 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-0171-2012
Status: Terminated
Initiated: 2010-11-18
Posted: 2011-11-08
Terminated: 2011-11-09
Recalling firm: ZimVie US Corp LLC
Product: ***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n 08940 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. The Thread form titanium screws (cylindrical dental implants) designed to be placed into mandibular or maxillary jaws in order to affix a dental prosthesis (edentulous or partially edentulous segments) that replaces 1 or more missing teeth.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The product may contain a manufacturing defect, that 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: The firm sent an Urgent: Medical Device Recall letter, dated November 2010, to notify customers that received the Osseotite Certain Implant (IOSS511) of the problem. The customers were instructed to return the unopened device(s) to Biomet 3i for replacement. If customers notice an issue, they were to contact Customer Service at 1-800-342-5454 for assistance. Customers were to respond via fax and return the implant(s) to BIOMET 3i using the address and incident number provided. Customers with questions or concerns were instructed to contact Mark Mashburn at 561-776-6906.
Quantity in commerce: 241
Distribution: Worldwide Distribution -- USA , BR, JP, TW, CA, Germany, and Guam.
Product codes and lots: Lot #910695

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)