CLASS II Device recall · Reported 23 Jul 2014 · FDA Enforcement Report
Dental Tapered Screw-Vent Implant recalled by Zimmer
Zimmer is recalling Dental Tapered Screw-Vent Implant, distributed nationwide in the US. The recall was initiated on 25 Jun 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-2050-2014
- FDA event ID
- 68584
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jun 2014
- FDA classified
- 14 Jul 2014
- Reported
- 23 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Dental Devices
Timeline
| 25 Jun 2014 | Recall initiated by company | |
| 14 Jul 2014 | Classified by FDA | +19 days |
| 23 Jul 2014 | Published in enforcement report | +9 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 conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.
Which lots are affected?
Catalog Number TSVT6B13, Lot Number 62284006. 5-year expiration. January 2018.
Where was it sold?
Nationwide Distribution.
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.
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| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
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