Recall archive / FDA device enforcement
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000 — FDA record Z-1168-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 16, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
- Reason
- 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
- Classification
- Class II
- Recalling firm
- W&H DENTALWERK BUERMOOS GMBH
- Quantity
- 160 pieces
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1168-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 28, 2024
- Recall initiation date
- Jan 16, 2024
- Center classification date
- Feb 20, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.