W&H Dentalwerk has recalled 160 units of its Surgical handpiece S-12 used for dental treatments because the devices were incorrectly labeled during production. The handpieces are marked as '1:1' speed on the body, but they are actually '1:2' speed increasing handpieces. This labeling error could lead a dental professional to operate the tool at an unintended speed during a surgical procedure. These devices were distributed nationwide in the United States and several other countries between January and February 2024.
The incorrect marking causes the handpiece to operate at a different speed than the user expects based on the label. This mismatch between the indicated and actual speed could lead to surgical errors or tissue damage during dental procedures.
Correction of laser marking or device replacement.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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