Z-1961-2013Class II

Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)

Name: Z-1961-2013 Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
Creator: Biomet 3i, LLC
Published: 2013-05-10
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2013-05-10 / Terminated / root cause: labeling and UDI

FDA source

Biomet 3i, LLC began a recall of Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L) on 2013-05-10. FDA classified it as Class II and gives the reason as "A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being...". 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-1961-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-10
Posted: 2013-08-13
Terminated: 2014-08-13
Recalling firm: ZimVie US Corp LLC
Product: Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm issued "Urgent Medical Device Recall" notification letters to their customers dated May 10, 2013. The notification described the issue and provided recommendations actions regarding affected product. Customers with questions may contact 1 800-342-5454.
Quantity in commerce: 33
Distribution: Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.
Product codes and lots: Lot number: 2012101530 Exp 2017/12 Catalog #: BNSS513

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1961-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1960-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-13
Z-1961-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-13

Product code DZE

K122300Class IIT3 Dental ImplantBiomet 3i / cleared 2013-01-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)