Straumann Dental Implant Recall Due to Incorrect Component Assembly
Straumann USA is recalling 6 units of Bone Level Tapered Dental Implants because they were assembled with the wrong transfer piece.
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 component mismatch that could affect the fit of the implant, but no injuries or illnesses are reported in the source text.
Plain-English summary
Straumann USA, LLC is recalling 6 units of Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim (Article Number: 021.5308). The recall is due to a manufacturing error where the implants were assembled with a Narrow Connect (NC) transfer piece instead of the intended Regular Connect (RC) transfer piece.
The affected units are from Lot number GY030 with an expiration date of 2019-04. These dental implants are intended for surgical placement in the maxillary and/or mandibular arches to support prosthetic restorations. The distribution was limited to the states of Florida and Massachusetts.
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 Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially…
- Manufacturer
- Straumann USA, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 6
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: GY030 Exp. 2019-04
Distribution
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