Straumann recall: Bone Level Tapered
Straumann USA LLC is recalling Straumann Bone Level Tapered – 175 units. The U.S. Food and Drug Administration published the recall on August 19, 2026; it began on July 16, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Straumann Bone Level Tapered |
| Brand | Straumann |
| Company | Straumann USA LLC |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 16, 2026 |
| Published by FDA | August 19, 2026 |
| Quantity | 175 units |
| Recall ID | 99441 |
Recalled products
- Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
- FDA recall number
- Z-2935-2026
- Codes, lots and dates
- UDI/DI 7630031707055, Lot ZVFV5
- Quantity
- 175 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99441
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Andover, MA, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99441, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Straumann recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 23, 2026 |  Straumann recall: GM Helix ImplantMedical devices · 216 | There is a discrepancy between the product identification on the packaging and the dimensi… Serious | FDA Class II |
| Aug 19, 2026 | Straumann recall: GM Helix ImplantMedical devices · 417 US | There may be a mismatch between the implant contained inside the packaging and the informa… Serious | FDA Class II |
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| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Straumann Straumann Bone Level Tapered recalled?
Yes. Straumann USA LLC recalled it on July 16, 2026; FDA published it August 19, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it 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 it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.