Z-0810-2010

LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made...

Name: Z-0810-2010 LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made...
Creator: Biomet 3i, LLC
Published: 2009-11-23
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2009-11-23 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile. BIOMET 3i 4555 Riverside Drive... on 2009-11-23. The reason FDA records is "Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility". 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-0810-2010
Status: Terminated
Initiated: 2009-11-23
Posted: 2010-02-22
Terminated: 2010-12-15
Recalling firm: ZimVie US Corp LLC
Product: LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile. BIOMET 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA. For use on tissue supported removable over-dentures on 2 to 4 implants, partially edentulous overdentures with one or more implants, limited interarch distance, angle correction with up to 40 degrees between divergent implants.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Each US customer will be contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i will perform a follow-up of each call with a faxed letter. The Urgent: Medical Device Recall letter, dated 11/23/2009, identified the affected product and asked customers to return unused product for replacement. The letter also explained the clinical implications and asked customers to respond with the attached response fax and then return the abutment(s) to BIOMET 3i. Questions or concerns can be directed to Kelly Taylor at 561-776-6906.
Quantity in commerce: 97
Distribution: Worldwide Distribution -- USA, Middle East, Italy, Europe, and Greece.
Product codes and lots: Lot 877423

Product code DZE

K012911Class II3I Locater Abutment SystemImplant Innovations, Inc. / cleared 2001-09-28

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)