FDA Device recall Z-1823-2017
Tapered SwissPlus Implant System, Model No. SPB10
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of Tapered SwissPlus Implant System, Model No. SPB10 by Zimmer Dental, citing it was manufactured with the minor diameter of the internal thread that is below specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1823-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-20 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Dental |
| Distribution | n/a |
Product
Tapered SwissPlus Implant System, Model No. SPB10
Reason
It was manufactured with the minor diameter of the internal thread that is below specification.
Identifiers
| code_info | Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731 |
|---|
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 - Tapered Screw-Vent MTX Model TSVTB11
FDA Device · Class II · 2017-12-27 · Zimmer Dental
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1823-2017%22
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