Straumann Recalls Neodent GM Mini Conical Abutments Due to Label Mismatch
Straumann Manufacturing is recalling 21 units of Neodent GM Mini Conical Abutments because the laser-engraved label does not match the item in the package.
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, and the hazard involves a labeling error that could lead to the use of incorrect medical components, fitting the criteria for moderate severity.
Plain-English summary
Straumann Manufacturing, Inc. is recalling 21 units of Neodent GM Mini Conical Abutments. These are intermediary prosthetic components used in dental implant procedures to support final prostheses. The specific lot number is 800327510.
The recall was initiated because the laser-engraved label on the product does not match the item contained in the package. This discrepancy could lead to the use of incorrect components during dental procedures.
The affected products were distributed in the United States, specifically in the states of Georgia, Texas, and Virginia. Healthcare professionals and patients who have received these specific abutments should contact Straumann Manufacturing for further instructions on how to proceed.
The recalled product
- Product
- Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different…
- Manufacturer
- Straumann Manufacturing, Inc.
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 21
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: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510
Distribution
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