Food, drugs, devices › Straumann USA LLC
Device recall: Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endos
Straumann USA LLC (Andover, MA) initiated this device recall on 16 Jul 2026; FDA lists 1 product record under event 99441, classified Class II.
FDA defines Class II as 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. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Straumann USA LLC has 18 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Straumann USA LLC, Andover, MA.
Reason for recall
"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."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2935-2026 | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form | 175 units | Class II | Ongoing | 19 Aug 2026 |
Context
Other enforcement events for Straumann USA LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Aug 2026 | GM Helix Implant, REF: 109.984; | Device | Class II | 1 |
| 13 Jul 2026 | GM Helix Implant, Endosseous Dental Implant Article No. 109.984 | Device | Class II | 1 |
| 27 Mar 2026 | Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments | Device | Class II | 2 |
| 17 Mar 2026 | Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; | Device | Class II | 2 |
| 6 Jan 2026 | WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM | Device | Class III | 1 |
| 17 Oct 2025 | Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; | Device | Class II | 1 |
| 1 May 2025 | GM Helix Acqua Implant, Article Number: 140.984 | Device | Class II | 2 |
| 17 Apr 2025 | WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. | Device | Class II | 1 |
| 14 Apr 2025 | Plus Initial Drill, Article Number: 103.170; | Device | Class II | 1 |
| 8 Mar 2025 | TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; | Device | Class II | 1 |
All 18 events for Straumann USA LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.