Straumann Bone Level Tapered recall: Labeling Error
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Why was Straumann Bone Level Tapered recalled?
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 7630031707055, Lot ZVFV5
- Product
- Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
- Recalling firm
- Straumann USA LLC
- Quantity
- 175 units
- Distribution
- US Nationwide distribution.
- Recall date
- August 19, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)