FDA Device recall Z-0863-2017
BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component dir…
- 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 TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component dir… 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-0863-2017 |
| 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 TITANIUM RETAINING SCREW 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 # LPCTSH Lots # 2016021930, 2016022074, 2016031247, 2016031248, 2016040024, 2016040025, 2016040064, 2016040898, 20…Part # LPCTSH Lots # 2016021930, 2016022074, 2016031247, 2016031248, 2016040024, 2016040025, 2016040064, 2016040898, 2016041632, 2016041635, 2016042030, and 2016042036 |
|---|
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-0863-2017%22
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