Z-2845-2016Class II

3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only

Name: Z-2845-2016 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only
Creator: Biomet 3i, LLC
Published: 2016-08-08
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2016-08-08 / Terminated / root cause: packaging

FDA source

Biomet 3i, LLC began a recall of 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only on 2016-08-08. FDA classified it as Class II and gives the reason as "Product was incorrectly packaged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2845-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-08
Posted: 2016-09-19
Terminated: 2019-08-06
Recalling firm: ZimVie US Corp LLC
Product: 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Product was incorrectly packaged.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: An Urgent Medical Device Removal Notice is being sent to Customers August 12, 2016, notifying them of the packaging of OSSEOTITE Certain Implant (4x11.5mm) in T3 Implant boxes. This recall is specific to Lot No. 2016031461. The material shipped within the box was described as being correct ,but only the box it was shipped in was incorrect. Customers were notified that there are no immediate or long term health consequences. In the notification letter, customers are instructed to complete the Certificate of Acknowledgement, and to return it via email ([email protected]) if no product is on hand or to return the certificate with product by shipping materials to: Biomet 3i - Post-Market Returns. Replacement product will be sent to customers upon return. Customers were also advised to keep a copy of their Certificate of Acknowledgement. Further questions should be directed to 1-800 443-8166 between the hours of 8:00 AM and 6:00 PM, Monday thru Friday. For further questions, please call 1-800 342-5454.
Quantity in commerce: 92 units
Distribution: US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.
Product codes and lots: Model No: IOSS411; Lot No: 2016031461; UDI: (01)00844868007098(17)210401(10)2016031461.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2845-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2845-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-19

Product code DZE

K063341Class II3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. / cleared 2007-04-30

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)