Food, drugs, devices › Straumann USA LLC
Device recall: WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
FDA enforcement event 96726 is a device recall by Straumann USA LLC of Andover, MA, initiated 17 Apr 2025 and classified Class II, with 1 product record.
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. 85% of the 945 device enforcement events initiated in 2025 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
"Incorrect blister labelling."
Distribution
"Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1671-2025 | WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. | 1,786 units | Class II | Ongoing | 30 Apr 2025 |
Context
Other enforcement events for Straumann USA LLC
All 18 events for Straumann USA LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Incorrect blister labelling."
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: "Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden."
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.