Reported Sep 30, 2015 · Terminated

Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

Bien Air Dental SA

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: Bien Air Dental SA · Langgasse 60 · Biel/bienne, N/A · N/A

Is this the product you have?

  • Contra-Angles CA11L
  • EVO 15 Catalog numbers1600939-001 and 1600938-001 Used for generally dentistry procedures
Lot codes and dates
  • Catalog numbers1600939-001 and 1600938-001
  • Serial numbers concerned-
  • Ref1600939-001: Serial
  • numbers included in the following range15B0001
  • up to 15F0011 - Ref1600938-001: Serial
  • numbers included in the following range15B0007 up to 15F0027
Amount recalled
112 (U.S.)

Where it was sold

Why it was recalled

Possible loosening of the dental tool, which may lead to potential swallowing of the tool.

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 Mar 31, 2016 · Data as of Sep 19, 6:07 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.