FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
- Recall number
- Z-2141-2019
- Recalling firm
- Biomet 3i, LLC
- Product
- CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
- Status
- Terminated
- Initiated
- 2019-02-26
- Posted
- not on file
- Terminated
- 2020-06-15
- Reason
- During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
- Root cause
- Process control
- Action
- The firm disseminated the notices by email on 02/26/2019. The letter requested that the dental laboratories quarantine and return any unused product and to further notify the affected clinician referral.
- Quantity
- 17 units
- Distribution
- Nationwide and Puerto Rico, Canada, and Australia
- Lot, serial or model codes
- Lot Numbers/UDI: 8442191-1/(01)00844868031178(10)8442191-1 8442751-1/(01)00844868031178(10)8442751-1 8441857-1/(01)00844868031178(10)8441857-1 8442548-1/(01)00844868031178(10)8442548-1 8442504-1/(01)00844868031178(10)8442504-1 8442556-1/(01)00844868031178(10)8442556-1 8442556-2/(01)00844868031178(10)8442556-2 8442556-3/(01)00844868031178(10)8442556-3 8442556-4/(01)00844868031178(10)8442556-4 8443047-1/(01)00844868031178(10)8443047-1 8443059-1/(01)00844868031178(10)8443059-1 8443071-2/(01)00844868031178(10)8443071-2 8443071-3/(01)00844868031178(10)8443071-3 8443085-1/(01)00844868031178(10)8443085-1 8442164-1/(01)00844868031178(10)8442164-1 8443036-1/(01)00844868031178(10)8443036-1 8443036-2/(01)00844868031178(10)8443036-2
- 510(k) numbers
- ["K052648","K102209"]
- 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