Straumann Plus Initial Drill Recalled for Missing Laser Engraving
Straumann USA is recalling 288 units of Plus Initial Drill due to missing laser engraving on the 7 mm component. The defect may affect product identification.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported injuries or hospitalizations. The defect is a manufacturing/identification issue (missing laser engraving), which constitutes a minor labeling error without reported harm.
Plain-English summary
Straumann USA LLC is recalling 288 units of the Plus Initial Drill (Article Number 103.170), Lot LNWT8.
The recalled batch was manufactured without the laser engraving on the 7 mm component. This defect may affect product identification and traceability of the drilling instrument.
The affected product was distributed nationwide in the United States (Arizona, California, Florida, Georgia, Illinois, Indiana, Minnesota, North Carolina, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, Virginia, and Wisconsin) and internationally in Brazil, Germany, India, Indonesia, Portugal, Romania, Spain, Switzerland, and Ukraine.
For further instructions regarding this recall, customers should contact Straumann USA LLC or consult the official FDA recall announcement.
The recalled product
- Product
- Plus Initial Drill, Article Number: 103.170;
- Manufacturer
- Straumann USA LLC
- Hazard
- mis-labeling
- identification-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Article Number: 103.170
- UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8
- Lot Number: LNWT8
Distribution
Distributed nationwide across the United States.
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