Straumann Dental Implant Screw Recall Due to Incorrect Component
Straumann USA is recalling 14 dental implant sets because the included screw was not the correct Narrow CrossFit model.
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 minor labeling or component error (incorrect screw) without reported injuries or illnesses.
Plain-English summary
Straumann USA, LLC is recalling 14 units of the Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. The recall was initiated because the sets contained an incorrect screw (RC) instead of the intended Narrow CrossFit (NC) Screw for the CARES NC Abutment ZrO2.
The affected products were distributed nationwide in the United States, including in Florida, Indiana, Louisiana, New York, and Texas. The specific lot codes for the recalled items are listed in the agency's official records.
Consumers and healthcare providers who have purchased these specific dental implant sets should contact Straumann USA, LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a…
- Manufacturer
- Straumann USA, LLC
- Category
- Medical Device — Dental Implant
- Affected units
- 14
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 (14)
- 26217US_10008_00_b00
- 25262US_10115_00_b05
- 25262US_10115_00_b06
- 21408US_10073_00_b01
- 26199US _10021_00_b00
- 25143US_ 10215_00_ b01
- 25267US_10278- 00_ b01
- 25267US _10280_ 00_b01
- 25267US_ 1280_ 00_b03
- 25310US_10342_03_b01
- 25310US_10342_03_b03
- 25310US_10342_03_b05
- 25310US_10345_00_b01
- 26249US_10019_00_b01
Distribution
Distributed nationwide across the United States.
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