FDA Device recall Z-0284-2018
Tapered Screw-Vent MTX Model TSVTB11
- FDA Device
- Class II
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class II recall of Tapered Screw-Vent MTX Model TSVTB11 by Zimmer Dental, citing some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0284-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-20 |
| Published | 2017-12-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Dental |
| Distribution | n/a |
Product
Tapered Screw-Vent MTX Model TSVTB11
Reason
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Identifiers
| code_info | lot,#63519794; UDI: (01)00889024019935 (17)211130 (10)63519794 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Zimmer Dental
- Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only
FDA Device · Class II · 2018-09-12 · Zimmer Dental - Tapered Screw-Vent MTX, Dental Implant, sterile
FDA Device · Class II · 2018-04-04 · Zimmer Dental - Tapered Screw-Vent MTX, Dental Implant, sterile
FDA Device · Class II · 2018-04-04 · Zimmer Dental - Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer…
FDA Device · Class II · 2017-12-27 · Zimmer Dental - Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Ma…
FDA Device · Class II · 2017-12-27 · Zimmer Dental
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0284-2018%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.