FDA Device recall Z-1190-2018
Tapered Screw-Vent MTX, Dental Implant, sterile
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of Tapered Screw-Vent MTX, Dental Implant, sterile by Zimmer Dental, citing two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1190-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-29 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Dental |
| Distribution | US |
Product
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Reason
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Identifiers
| code_info | Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437. |
|---|
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-1190-2018%22
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