Reported Nov 21, 2018 · Terminated

Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be…

Straumann Manufacturing, 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: Straumann Manufacturing, Inc. · 60 Minuteman Rd · Andover, MA · 01810-1008

Is this the product you have?

  • Neodent¿ GM
  • Mini Conical Abutment - Product UsageMini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit
  • prostheses onto implants Article Number115244
Lot codes and dates
  • Lot Number800327510
  • UDI(01)07899878026488(11)171110(17)221110(10)800327510
Amount recalled
21 units

Where it was sold

Why it was recalled

Laser engraved label does not match with the item in the package

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 Jan 28, 2019 · Data as of Sep 19, 6:53 PM UTC

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