FDA Device recall Z-0861-2017
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component…
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component… by Biomet 3i, citing A limited number of product pouches may not have been sealed during packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0861-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-14 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet 3i |
| Distribution | n/a |
Product
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER 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
Reason
A limited number of product pouches may not have been sealed during packaging.
Identifiers
| code_info | Part # LPCTC2 Lot's # 2015111121, 2015120492, 2015120495, 2015120497, 2015121108, 2015121114, 2015121115, 2016011524, 2…Part # LPCTC2 Lot's # 2015111121, 2015120492, 2015120495, 2015120497, 2015121108, 2015121114, 2015121115, 2016011524, 2016031197, 2016031875, 2016031878, 2016050008, 2016060232, 2016060233, 2016060234, and 2016062347 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0861-2017%22
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