FDA Device recall Z-1411-2015
OSSEOTITE Certain 2 Implant Rx only
- FDA Device
- Class II
- terminated
- Published 2015-04-22
On 2015-04-22 the FDA classified a Class II recall of OSSEOTITE Certain 2 Implant Rx only by Biomet 3i, citing endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1411-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-07 |
| Published | 2015-04-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet 3i |
| Distribution | US |
Product
OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
Reason
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Identifiers
| code_info | Implant PN # XIFOSM311 Lot # 2014051368 Exp date 12/03/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1411-2015%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.