FDA Device recall Z-0153-2015
Spline Twist Implant, HA 3.25mmD X 15mmL
- FDA Device
- Class II
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class II recall of Spline Twist Implant, HA 3.25mmD X 15mmL by Zimmer Dental, citing zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0153-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-01 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer Dental |
| Distribution | US |
Product
Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
Reason
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Identifiers
| code_info | Lot No. 61792330 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 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-0153-2015%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.