CLASS II Device recall · Reported 27 Dec 2017 · FDA Enforcement Report
Tapered Screw-Vent MTX recalled by Zimmer Dental
Zimmer Dental is recalling Tapered Screw-Vent MTX. The recall was initiated on 20 Nov 2017 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-0284-2018
- FDA event ID
- 78635
- Recalling firm
- Zimmer Dental, Carlsbad, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2017
- FDA classified
- 21 Dec 2017
- Reported
- 27 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Nov 2017 | Recall initiated by company | |
| 21 Dec 2017 | Classified by FDA | +31 days |
| 27 Dec 2017 | 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
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
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
Tapered Screw-Vent MTX Model TSVTB11
Where it was distributed
US, Canada, France, Italy, Spain, Germany
Questions about this recall
Why was it recalled?
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Which lots are affected?
lot,#63519794; UDI: (01)00889024019935 (17)211130 (10)63519794
Where was it sold?
US, Canada, France, Italy, Spain, Germany
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.
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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