Reported Feb 28, 2024 · Ongoing

W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000

W&h Dentalwerk Buermoos GmbH

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: W&H DENTALWERK BUERMOOS GMBH · Ignaz Glaser Strase 53 · BUERMOOS, N/A · N/A

Is this the product you have?

  • W&H Surgical handpiece S-12. For Surgical treatment
  • of dental hard tissue Model Number30061000
Lot codes and dates
  • UDI-DIJ021300610011
  • US Serial Numbers

    160 of 160 codes

    • 04931
    • 04932
    • 04933
    • 04934
    • 04935
    • 04936
    • 04937
    • 04938
    • 04939
    • 04940
    • 04941
    • 04942
    • 04943
    • 04944
    • 04945
    • 04946
    • 04947
    • 04948
    • 04949
    • 04950
    • 04951
    • 04952
    • 04953
    • 04954
    • 04955
    • 04956
    • 04957
    • 04958
    • 04959
    • 04960
    • 04961
    • 04962
    • 04963
    • 04964
    • 04965
    • 04966
    • 04967
    • 04968
    • 04969
    • 04970
    • 04971
    • 04973
    • 04974
    • 04975
    • 04976
    • 04977
    • 04978
    • 04979
    • 04980
    • 04981
    • 04982
    • 04983
    • 04984
    • 04995
    • 04996
    • 04999
    • 05004
    • 05005
    • 05006
    • 05007
Amount recalled
160 pieces

Where it was sold

  • Nationwide

Why it was recalled

1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece

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, 7:38 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.