Straumann Twist Drill PRO Recalled for Tolerance Specification Defects
Straumann Manufacturing is recalling 120 units of Twist Drill PRO dental implant accessories 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 involves a functional defect (inability to insert into handpiece) rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Straumann Manufacturing, Inc. is recalling 120 units of the Straumann Twist Drill PRO (4.2mm, long, 41mm, SS-Non sterile), Article Number 044.255, Lot Number LV455. These dental implant accessories are intended to prepare the osteotomy site for surgical dental implant placement.
The recall was initiated because the drills cannot be inserted into handpieces due to tolerance specifications not being met. This defect prevents the proper use of the device during surgical procedures.
The affected products were distributed nationwide. Consumers and healthcare providers should stop using the recalled drills and contact Straumann Manufacturing for further instructions or a replacement.
The recalled product
- Product
- Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and…
- Manufacturer
- Straumann Manufacturing, Inc.
- Hazard
- Affected units
- 120
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 (1)
- Lot Number: LV455
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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