CLASS II Device recall · Reported 5 Nov 2014 · FDA Enforcement Report
Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X Platform recalled
Zimmer Dental is recalling Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X Platform, 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-0154-2015
- 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
- Other Medical 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
Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent 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
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. 62659204, 62658448
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 69392| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Spline Twist Implant, HA 3.25mmD X 15mmL recalled by Zimmer Dental | 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 |
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