FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
- Recall number
- Z-2845-2016
- Recalling firm
- Biomet 3i, LLC
- Product
- 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
- Status
- Terminated
- Initiated
- 2016-08-08
- Posted
- not on file
- Terminated
- 2019-08-06
- Reason
- Product was incorrectly packaged.
- 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 (postmarket@zimmerbiomet.com) 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
- 92 units
- Distribution
- US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.
- Lot, serial or model codes
- Model No: IOSS411; Lot No: 2016031461; UDI: (01)00844868007098(17)210401(10)2016031461.
- 510(k) numbers
- ["K063341"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1038806
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28