OSSEOTITE CERTAIN recallZ-2845-2016 · Biomet 3i, LLC · initiated Aug 8, 2016
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet 3i, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product was incorrectly packaged.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-2845-2016
- Status
- Terminated
- Initiated by the company
- Aug 8, 2016
- Recalling firm
- Biomet 3i, LLC
- Quantity
- 92 units
- Product code
- DZE
- FDA submissions
- K063341
- Distribution
- US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.
Product description
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Code information (models, lots, serial numbers)
Model No: IOSS411; Lot No: 2016031461; UDI: (01)00844868007098(17)210401(10)2016031461.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OSSEOTITE® CERTAIN® IOSS411ZimVie US Corp LLC · IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall16 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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