FDA Device recall Z-0564-2016
Radiographic Transparency for Certain and External Connection Tapered Implants
- FDA Device
- Class II
- terminated
- Published 2016-01-06
On 2016-01-06 the FDA classified a Class II recall of Radiographic Transparency for Certain and External Connection Tapered Implants by Biomet 3i, citing images contained within radiographic transparency ART 1036 are undersized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0564-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-16 |
| Published | 2016-01-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet 3i |
| Distribution | CA, CO, FL, HI, IL, MA, MI, MO, NY, OH, PR, SC, TX, VA, WI, WV |
Product
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
Reason
Images contained within radiographic transparency ART 1036 are undersized.
Identifiers
| code_info | Model Number: ART 1036, Rev. C 03/13; Purchase Order # 184427. |
|---|
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-0564-2016%22
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