FDA Device recall Z-2963-2018
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only
- FDA Device
- Class II
- terminated
- Published 2018-09-12
On 2018-09-12 the FDA classified a Class II recall of Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only by Zimmer Dental, citing dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2963-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-10 |
| Published | 2018-09-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Dental |
| Distribution | US |
Product
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Reason
Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
Identifiers
| code_info | Outer Package Label: LOT: 63781164, UDI: (01) 00889024019621 (10) 63781164 (17) 220930 (10) 63781164; Inner Package L…Outer Package Label: LOT: 63781164, UDI: (01) 00889024019621 (10) 63781164 (17) 220930 (10) 63781164; Inner Package Label: LOT: 63773888, UDI: (01) 00889024019508 (17) 220930 (10)63773888. |
|---|
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
- 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 - Tapered Screw-Vent MTX Model TSVTB11
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-2963-2018%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.