Straumann Bone Level Implant Recalled for Misalignment with Transfer Piece
Straumann Manufacturing, Inc. is recalling 33 Bone Level Implants due to misalignment with the Loxim transfer piece markings, which 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that results in incorrect implant positioning, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Straumann Manufacturing, Inc. is recalling 33 pieces of the Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP (Article Number: 021.4512). The recall is limited to Lot Number LT123, which was distributed nationwide.
The recall was initiated because of a misalignment with the Loxim transfer piece markings. This defect may cause the positioning of the implant to be incorrect for optimal restoration.
Healthcare professionals and patients who have used or are considering using these specific implants should contact Straumann Manufacturing, Inc. for further instructions regarding the recall and potential replacement or correction.
The recalled product
- Product
- Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
- Manufacturer
- Straumann Manufacturing, Inc.
- Category
- Medical Device — Dental Implant
- Affected units
- 33
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: LT123
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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