CLASS II Device recall · Reported 5 Nov 2014 · FDA Enforcement Report
Spline Twist Implant, HA 3.25mmD X 15mmL recalled by Zimmer Dental
Zimmer Dental is recalling Spline Twist Implant, HA 3.25mmD X 15mmL, distributed nationwide in the US. The recall was initiated on 1 Oct 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0153-2015
- FDA event ID
- 69392
- Recalling firm
- Zimmer Dental, Carlsbad, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Oct 2014
- FDA classified
- 30 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 1 Oct 2014 | Recall initiated by company | |
| 30 Oct 2014 | Classified by FDA | +29 days |
| 5 Nov 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.
Questions about this recall
Why was it recalled?
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Which lots are affected?
Lot No. 61792330
Where was it sold?
Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 69392This product is part of a recall event; the main page for the event is Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X Platform recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X Platform recalled | Zimmer Dental | Other | Nationwide |
More recalls from Zimmer Dental
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Outer Package Label: Tapered Screw-Vent Implant System recalled | Zimmer Dental | Packaging Defects | Nationwide |
| Device | CLASS II | Tapered Screw-Vent MTX, Dental Implant, sterile recalled | Zimmer Dental | Labeling Errors | Nationwide |
| Device | CLASS II | Tapered Screw-Vent MTX, Dental Implant, sterile recalled | Zimmer Dental | Labeling Errors | Nationwide |
| Device | CLASS II | Instrument Kit System, Tapered Screw-Vent Implant System recalled | Zimmer Dental | Other | Nationwide |
| Device | CLASS II | Instrument Kit System, Tapered Screw-Vent Implant System recalled | Zimmer Dental | Other | Nationwide |
Other Dental Devices recalls
All 426| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |