FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
- Recall number
- Z-0838-2017
- Recalling firm
- Biomet 3i, LLC
- Product
- BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
- Status
- Terminated
- Initiated
- 2016-09-14
- Posted
- not on file
- Terminated
- 2019-07-26
- Reason
- A limited number of product pouches may not have been sealed during packaging.
- Root cause
- Employee error
- Action
- BIOMET 3i will conduct this recall with Dentists and Health Care Professionals. Notices will be sent via a carrier with a traceable method of delivery by BIOMET 3i team members. " All dentists and health care professionals will be notified via courier: - Dentists and health care professionals will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their control. - Dentists and health care professionals will return on-hand product to BIOMET 3i via a courier agency and ensure all of their products are accounted for using the form provided in the letter. - Dentists and health care professionals will complete and return the Inventory Return Certification Form to the fax number or email address provided. International distributors will be notified via email. Further distribution of the international customer notices will be sent through the local and regional distributors following local language translation. Communications will occur as translations are completed and are anticipated to occur during the week of September 12, 2016.1233. Customers with questions were instructed to call the customer call center at +44 (0) 800 652-1233.
- Quantity
- 123
- Distribution
- Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
- Lot, serial or model codes
- Part # ILPC441 Lot # 2016021500
- 510(k) numbers
- ["K092341"]
- PMA numbers
- not on file
- Product code
- NHA
- 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