FDA Device recall Z-2425-2016
O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 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-2425-2016 |
| 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
O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
Reason
Pouches may not have been sealed during packing.
Identifiers
| code_info | Lot # 1014104, 1022991, 1033058, 1041417, 1052716, 1054542, 1060675, 1069646, 1088483, 1094776, 1106610, 1129686, 11412…Lot # 1014104, 1022991, 1033058, 1041417, 1052716, 1054542, 1060675, 1069646, 1088483, 1094776, 1106610, 1129686, 1141289, 1168523, 1168829, 1172024, and 996069. |
|---|
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-2425-2016%22
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