W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
FDA Device Recall #Z-1168-2024 — Class II — January 16, 2024
Recall Summary
| Recall Number | Z-1168-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 16, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | W&H DENTALWERK BUERMOOS GMBH |
| Location | BUERMOOS, N/A |
| Product Type | Devices |
| Quantity | 160 pieces |
Product Description
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
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
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden.
Lot / 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
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.