Straumann Dental Implant Drill Set Recalled for Incorrect Drill
Straumann USA is recalling dental implant drill sets that may contain incorrect drills. The recall covers 362 pieces distributed nationwide and internationally.
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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any injuries, illnesses, or deaths, and the hazard is limited to the potential use of an incorrect drill component.
Plain-English summary
Straumann USA, LLC is recalling 362 pieces of the Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set. The recall is being conducted because the drill set may contain an incorrect drill.
The affected products were distributed nationwide in the United States to the states of AZ, CA, CO, CT, FL, IA, IL, IN, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OH, OK, OR, PA, RI, TX, VA, and WV. Additionally, the products were distributed worldwide in Austria, Australia, Canada, Germany, Spain, Finland, France, the United Kingdom, the Netherlands, Belgium, Switzerland, and Italy through the Institut Straumann AG distribution network. The specific lot numbers involved are GY037, HA443, HE874, and HL216.
Dental professionals and consumers should check their inventory for these specific article numbers and lot numbers. If the product is found, it should be removed from use and returned to the distributor or manufacturer for instructions on replacement or refund.
The recalled product
- Product
- Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
- Manufacturer
- Straumann USA, LLC
- Hazard
- Affected units
- 362
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 (4)
- Lot Numbers: GY037
- HA443
- HE874
- HL216
Distribution
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