Z-1363-2008

BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL

Name: Z-1363-2008 BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL
Creator: Biomet 3i, Inc.
Published: 2008-02-07
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2008-02-07 / Terminated / root cause: labeling and UDI

FDA source

Biomet 3i, Inc. began a recall of BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL on 2008-02-07. The reason FDA records is "Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1363-2008
Status: Terminated
Initiated: 2008-02-07
Posted: 2015-06-25
Terminated: 2008-07-10
Recalling firm: ZimVie US Corp LLC
Product: BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Each USA customer was contacted by telephone and then by letter, Urgent Medical Device Recall, dated 2/15/2008, sent by fax. International customers were first contacted by E-mail then by fax letter also. Each customer was instructed to check their respective inventory for the affected part and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory for product return. They were also instructed to return the affected product to Biomet 3i.
Quantity in commerce: 100
Distribution: Worldwide.
Product codes and lots: Lot Number: 765291

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