Reported Mar 27, 2024 · Ongoing

impression coping, repositionable, short, screw-retained, PF 4.0

Thommen Medical AG

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: Thommen Medical AG · Eschenweg 3 · Bettlach · N/A

Is this the product you have?

  • impression coping, repositionable, short, screw-retained, PF 4.0
Lot codes and dates
  • Article No. 3.03.079
  • UDI/DI
    • 07640156475463
    • Lot No. 30972
Amount recalled
20 units

Where it was sold

Why it was recalled

The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.

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

Data as of Sep 19, 7:35 PM UTC

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