FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - 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-2144-2019
- Recalling firm
- Biomet 3i, LLC
- Product
- CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - 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
- 49 units
- Distribution
- Nationwide and Puerto Rico, Canada, and Australia
- Lot, serial or model codes
- Lot Numbers/UDI: 8442579-2/(01)00844868031390(10)8442579-2 8442701-1/(01)00844868031390(10)8442701-1 8442701-3/(01)00844868031390(10)8442701-3 8442692-1/(01)00844868031390(10)8442692-1 8442681-1/(01)00844868031390(10)8442681-1 8442663-1/(01)00844868031390(10)8442663-1 8442688-1/(01)00844868031390(10)8442688-1 8442837-1/(01)00844868031390(10)8442837-1 8442837-2/(01)00844868031390(10)8442837-2 8442657-1/(01)00844868031390(10)8442657-1 8442657-2/(01)00844868031390(10)8442657-2 8442674-1/(01)00844868031390(10)8442674-1 6867796-1/(01)00844868031390(10)6867796-1 8442805-1/(01)00844868031390(10)8442805-1 8442895-1/(01)00844868031390(10)8442895-1 8442811-1/(01)00844868031390(10)8442811-1 8442841-1/(01)00844868031390(10)8442841-1 8442720-1/(01)00844868031390(10)8442720-1 8442799-2/(01)00844868031390(10)8442799-2 8442765-1/(01)00844868031390(10)8442765-1 8442914-2/(01)00844868031390(10)8442914-2 8442944-1/(01)00844868031390(10)8442944-1 8443029-2/(01)00844868031390(10)8443029-2 8442940-2/(01)00844868031390(10)8442940-2 8443035-1/(01)00844868031390(10)8443035-1 8442948-1/(01)00844868031390(10)8442948-1 8443044-1/(01)00844868031390(10)8443044-1 8442965-1/(01)00844868031390(10)8442965-1 8442954-1/(01)00844868031390(10)8442954-1 8442949-1/(01)00844868031390(10)8442949-1 8442970-1/(01)00844868031390(10)8442970-1 8442930-1/(01)00844868031390(10)8442930-1 8443242-1/(01)00844868031390(10)8443242-1 8443098-1/(01)00844868031390(10)8443098-1 8442937-1/(01)00844868031390(10)8442937-1 8443046-1/(01)00844868031390(10)8443046-1 8442927-1/(01)00844868031390(10)8442927-1 8442936-1/(01)00844868031390(10)8442936-1 8442935-1/(01)00844868031390(10)8442935-1 8442997-1/(01)00844868031390(10)8442997-1 8443187-1/(01)00844868031390(10)8443187-1 8443018-1/(01)00844868031390(10)8443018-1 8443010-1/(01)00844868031390(10)8443010-1 8443230-1/(01)00844868031390(10)8443230-1 8443102-1/(01)00844868031390(10)8443102-1 8443231-1/(01)00844868031390(10)8443231-1 8443193-1/(01)00844868031390(10)8443193-1 8443248-1/(01)00844868031390(10)8443248-1 8443213-1/(01)00844868031390(10)8443213-1
- 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