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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical handpiece S12

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  Class 2 Device Recall Surgical handpiece S12 see related information
Date Initiated by Firm January 16, 2024
Date Posted February 20, 2024
Recall Status1 Open3, Classified
Recall Number Z-1168-2024
Recall Event ID 93917
510(K)Number K080939  
Product Classification Handpiece, rotary bone cutting - Product Code KMW
Product W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue
Model Number: 30061000
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
Recalling Firm/
Manufacturer		 W&H DENTALWERK BUERMOOS GMBH
Ignaz Glaser Strase 53
53 IGNAZ-GLASER-STRASSE
BUERMOOS Austria
Manufacturer 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
FDA Determined
Cause 2		 Labeling False and Misleading
Action W&H Dentalwerk Burmoos GmbH issued Urgent Medical Device Voluntary Recall Letter on 12/16/23 to Distributors and End Users via email. Letter states reason for recall, health risk and action to take: This recall is carried out to the user level. Please return product to W&H Impex Inc. for disposal within two (2) months after receipt of this notification. Address for removal: W&H Impex Inc. Attn. Mona Miron Regulatory Affairs, Technical Service Manager 6490 Hawthorne Dr, Windsor, ON t +1 800 265 6277 The affected products will be exchanged and replaced by W&H Dentalwerk B¿rmoos GmbH. Instructions for acknowledgement: Please send back the included return response card. CONTACT INFORMATION: Mona Miron Regulatory Affairs Technical Service Manager W&H Impex Inc 6490 Hawthorne Dr, Windsor, ON t +1 800 265 6277 mona.miron@wh.com
Quantity in Commerce 160 pieces
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KMW and Original Applicant = W & H DENTALWERK BUERMOOS GMBH
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