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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93917

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 16, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
W&H DENTALWERK BUERMOOS GMBH

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1168-2024
Recall number
Z-1168-2024
Initiated
January 16, 2024
Classification
Class II
Status
Ongoing
Quantity
160 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

UDI-DI: J021300610011 US Serial Numbers: 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 05008 05009 05010 05011 05012 05013 05014 05015 05016 05017 05018 05019 05020 05021 05022 05023 05024 05025 05026 05027 05028 05029 05030 05031 05032 05033 05034 05035 05036 05037 05040 05041 05042 05043 05044 05045 05046 05047 05048 05049 05050 05051 05052 05053 05054 05055 05061 05062 05063 05064 05065 05066 05067 05068 05069 05070 05071 05072 05073 05074 05075 05076 05077 05078 05079 05080 05081 05082 05083 05084 05085 05086 05087 05088 05089 05090 05091 05092 05093 05094 05095 05096 05097 05098 05099 05100 05101 05102 05103 05104 05105 05111 05112 05113 05116 05117 05118 05119 05120 05121

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden.