FDA Device recall Z-2521-2016
Certain Gingihue TM 15 degree Angled Post Dental implants
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of Certain Gingihue TM 15 degree Angled Post Dental implants by Biomet 3i, citing pouches may not have been sealed during packing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2521-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-25 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet 3i |
| Distribution | US |
Product
Certain Gingihue TM 15 degree Angled Post Dental implants
Reason
Pouches may not have been sealed during packing.
Identifiers
| code_info | Item: IMPAP34G |
|---|
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-2521-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.