Straumann Dental Implant Recall Due to Incorrect Product Transfer Piece
Straumann USA is recalling 111 units of Bone Level Implants because the product transfer piece was fitted with a Narrow Connect instead of a Regular Connect.
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 defect is a component mismatch (Narrow Connect vs. Regular Connect) with no reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a potential functional defect rather than an immediate high-risk pathogen or structural failure with reported harm.
Plain-English summary
Straumann USA, LLC is recalling 111 units of Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim (Article Number: 021.4308). The recall is due to a manufacturing error where the product transfer piece was fitted with a Narrow Connect (NC) instead of the intended Regular Connect (RC). The affected units are identified by Lot number GY256.
The recall covers US Nationwide Distribution. Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Consumers and healthcare providers should stop using the affected units and contact Straumann USA, LLC for further instructions or a replacement.
The recalled product
- Product
- Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or…
- Manufacturer
- Straumann USA, LLC
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 111
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: GY256
Distribution
Distributed nationwide across the United States.
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