Straumann Dental Implant Drills Recalled for Tolerance Specification Failures
Straumann Manufacturing is recalling 165 dental implant drills because they cannot be inserted into handpieces due to tolerance specification failures.
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. The hazard is a functional defect (inability to insert into handpieces) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Straumann Manufacturing, Inc. is recalling 165 units of the Straumann Drill 1, short, 2.2mm, 33.0mm, SS-Non sterile dental implant accessory (Article Number: 044.210). The recall affects Lot Numbers LV463, MG783, and MH027, which were distributed nationwide.
The recall was initiated because the drills cannot be inserted into handpieces due to tolerance specifications not being met. These accessories are intended to prepare the osteotomy site for surgical dental implant placement.
Healthcare professionals and consumers who possess these specific lots should stop using the affected drills and contact Straumann Manufacturing for further instructions.
The recalled product
- Product
- Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement…
- Manufacturer
- Straumann Manufacturing, Inc.
- Hazard
- Affected units
- 165
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)
- Lot Number: LV463
- MG783
- MH027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Straumann Manufacturing, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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