Straumann Plus Initial Drill missing laser engraving marking
Straumann USA LLC is recalling Plus Initial Drill units (Article Number 103.170, Lot LNWT8) because the batch was produced without the required 7 mm laser engraving marking.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involving a manufacturing defect (missing laser engraving marking). The source text does not report any illnesses or injuries, and the defect is a labeling/identification issue rather than a safety hazard that poses direct risk of harm.
Plain-English summary
Straumann USA LLC is recalling Plus Initial Drill units (Article Number 103.170, Lot LNWT8) because the batch was produced without the laser engraving of 7 mm. This product is a surgical dental drill that has been distributed nationwide in the United States and internationally.
The affected units were distributed across the following U.S. states: Arizona, California, Florida, Georgia, Illinois, Indiana, Minnesota, North Carolina, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, Virginia, and Wisconsin. International distribution includes Brazil, Germany, India, Indonesia, Portugal, Romania, Spain, Switzerland, and Ukraine.
Consumers and healthcare providers who have this product should contact Straumann USA LLC for further guidance on the affected units.
The recalled product
- Product
- Plus Initial Drill, Article Number: 103.170;
- Manufacturer
- Straumann USA LLC
- Hazard
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
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