W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
Summary
The FDA issued a Class II for W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model by W&H DENTALWERK BUERMOOS GMBH. Reason: 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead.
Details
Source
Device Recall
External ID
Z-1168-2024
Action Date
2024-02-28
Status
Ongoing
Category
device
Product Description
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
Lot/Code Info: 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
Quantity Affected: 160 pieces
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
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-16
Company
BUERMOOS, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
W&H DENTALWERK BUERMOOS GMBH has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (W&H DENTALWERK BUERMOOS GMBH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does W&H DENTALWERK BUERMOOS GMBH have FDA actions?
W&H DENTALWERK BUERMOOS GMBH has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1168-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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