Z-0128-2008

Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm...

Name: Z-0128-2008 Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm...
Creator: Biomet 3i
Published: 2007-10-08
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2007-10-08 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i began a recall of Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410 on 2007-10-08. The reason FDA records is "Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform". 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-0128-2008
Status: Terminated
Initiated: 2007-10-08
Posted: 2008-01-17
Terminated: 2008-07-10
Recalling firm: ZimVie US Corp LLC
Product: Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Beginning on 9/27/07, Biomet 3i contacted its US consignees by telephone using a prepared script. Following telephone contact, Biomet 3i sent a recall letter, titled Urgent Medical Device Recall, by fax. The international consignees were contacted by email followed by a faxed letter. Each customer was requested to examine their inventory for the affected part and corresponding lot number, and return them to Biomet 3i.
Quantity in commerce: 114
Distribution: Worldwide Distribution - USA, Italy, France, Spain and UK.
Product codes and lots: Lot Number: 707303, Expiration Date: 08/31/2012

Product code NHA

K060291Class IIPreformance Temporary CylinderImplant Innovations, Inc. / cleared 2006-02-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)