CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report
Tapered SwissPlus Implant System recalled by Zimmer Dental
Zimmer Dental is recalling Tapered SwissPlus Implant System. The recall was initiated on 20 Mar 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-1823-2017
- FDA event ID
- 76746
- Recalling firm
- Zimmer Dental, Carlsbad, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Mar 2017
- FDA classified
- 14 Apr 2017
- Reported
- 26 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Mar 2017 | Recall initiated by company | |
| 14 Apr 2017 | Classified by FDA | +25 days |
| 26 Apr 2017 | 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
It was manufactured with the minor diameter of the internal thread that is below specification.
Product as listed by the FDA
Tapered SwissPlus Implant System, Model No. SPB10
Where it was distributed
Worldwide: ZA, FR, IT, IR
Questions about this recall
Why was it recalled?
It was manufactured with the minor diameter of the internal thread that is below specification.
Which lots are affected?
Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731
Where was it sold?
Worldwide: ZA, FR, IT, IR
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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|---|---|---|---|---|---|
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