Straumann Bone Level Implant Recalled for Misalignment with Transfer Piece
Straumann Manufacturing is recalling 70 Bone Level Implants because misalignment with the Loxim transfer piece may result in incorrect implant positioning.
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 incorrect positioning for restoration, which is a functional defect without reported serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Straumann Manufacturing, Inc. is recalling 70 units of the Straumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP (Article Number: 021.4510). The recall affects Lot Numbers LR810 and LT122, which were distributed nationwide.
The recall was initiated because the implants may be misaligned with the Loxim transfer piece markings. This misalignment can cause the positioning of the implant to be incorrect for optimal restoration.
Healthcare professionals and patients should contact Straumann Manufacturing for further instructions regarding the affected devices.
The recalled product
- Product
- Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
- Manufacturer
- Straumann Manufacturing, Inc.
- Category
- Medical Device — Dental Implant
- Affected units
- 70
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 (2)
- Lot Numbers: LR810
- LT122
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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