Reported Apr 26, 2017 · Terminated

Tapered SwissPlus Implant System, Model No. SPB10

Zimmer Dental Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Dental Inc · 1900 Aston Ave · Carlsbad, CA · 92008-7308

Is this the product you have?

  • Tapered SwissPlus Implant System, Model No. SPB10
Lot codes and dates
  • Lot #63498673
  • UDI(01) 008890240177 (10) 63498673 (17) 200731
Amount recalled
188 units

Why it was recalled

It was manufactured with the minor diameter of the internal thread that is below specification.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 1, 2017 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.