CLASS II Device recall · Reported 12 Sep 2018 · FDA Enforcement Report
Outer Package Label: Tapered Screw-Vent Implant System recalled
Zimmer Dental is recalling Outer Package Label: Tapered Screw-Vent Implant System, distributed nationwide in the US. The recall was initiated on 10 May 2018 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-2963-2018
- FDA event ID
- 80609
- Recalling firm
- Zimmer Dental, Carlsbad, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 May 2018
- FDA classified
- 31 Aug 2018
- Reported
- 12 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Dental Devices
Timeline
| 10 May 2018 | Recall initiated by company | |
| 31 Aug 2018 | Classified by FDA | +113 days |
| 12 Sep 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental 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. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Where it was distributed
Worldwide Distribution: US (nationwide) in states of: AL, CA, CO, CT, FL, GA, ID, IL, MA, MD, MI, MN, MO, NH, NJ, NY, PA,TN, TX, UT, VA, and WA; and to countries of: Australia, Bulgaria, Canada, Croatia, France, Germany, Italy, Portugal, and Spain.
Nationwide AlabamaCaliforniaColoradoConnecticutFloridaGeorgiaIdahoIllinoisMassachusettsMarylandMichiganMinnesotaMissouriNew HampshireNew JerseyNew YorkPennsylvaniaTennesseeTexasUtah
Questions about this recall
Is Outer Package Label: Tapered Screw-Vent Implant System recalled?
Yes. Zimmer Dental recalled Outer Package Label: Tapered Screw-Vent Implant System on 10 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2963-2018.
Why was it recalled?
Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
Which lots are affected?
Outer Package Label: LOT: 63781164, UDI: (01) 00889024019621 (10) 63781164 (17) 220930 (10) 63781164; Inner Package Label: LOT: 63773888, UDI: (01) 00889024019508 (17) 220930 (10)63773888.
Where was it sold?
Worldwide Distribution: US (nationwide) in states of: AL, CA, CO, CT, FL, GA, ID, IL, MA, MD, MI, MN, MO, NH, NJ, NY, PA,TN, TX, UT, VA, and WA; and to countries of: Australia, Bulgaria, Canada, Croatia, France, Germany, Italy, Portugal, and Spain.
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 21 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 | 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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