FDA Device recall Z-2141-2019
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as a…
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as a… by Biomet 3i, citing 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 posit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2141-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-26 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomet 3i |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot Numbers/UDI: 8442191-1/(01)00844868031178(10)8442191-1 8442751-1/(01)00844868031178(10)8442751-1 8441857-1/(01…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2141-2019%22
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