FDA Posts Class 2 Recalls for Two Straumann Full-Arch Implant Restorations

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Posted: May 8, 2026

FDA Posts Class 2 Recalls for Two Straumann Full-Arch Implant Restorations

Edited by Dentaltown staff

The U.S. Food and Drug Administration has posted two open Class 2 recalls covering Straumann USA LLC full-arch implant-abutment restorations after the manufacturer determined the products included an incorrect screw seat interface. Both recalls were posted April 29, 2026, and were initiated by the firm on March 27, 2026.

The recalls cover the Straumann n!ce PMMA Full-arch Restoration (Article 010.0304, recall number Z-1994-2026) and the Straumann n!ce Zr, HT, Full-arch Restoration (Article 010.0158, recall number Z-1995-2026). Eleven units across the two product lines are affected — five PMMA units and six zirconia units — and were distributed to consignees in Alabama, Arizona, Florida, Hawaii, Louisiana, Maryland, Ohio and Virginia.

Straumann USA notified consignees on or about March 27, 2026, by phone, mailed letter or email. Per the recall notices, recipients were instructed to examine inventory for affected product, cease use, quarantine any affected units on hand and arrange for return of all affected units, along with completion of a Customer Confirmation Form.

For restorations that had already been placed, the notices instruct consignees to contact Straumann to organize remakes and to schedule patients to return for replacement once the new restoration is available.

Both recalls remain classified and open, meaning corrective action by the manufacturer is still in progress. The FDA-determined cause is listed as under investigation by the firm. The affected products fall under FDA product code NHA, endosseous dental implant abutments, and were cleared under 510(k) numbers K242686 (PMMA) and K222836 (Zr).

Straumann USA LLC, headquartered in Andover, Massachusetts, is the U.S. subsidiary of Switzerland-based Institut Straumann AG. Practitioners with questions about affected inventory or in-mouth restorations are directed by the FDA notices to contact Jennifer M. Jackson at Straumann USA.

Sources:
FDA Class 2 Device Recall: Straumann n!ce PMMA Full-arch Restoration, posted April 29, 2026: accessdata.fda.gov/recall/219425
FDA Class 2 Device Recall: Straumann n!ce Zr, HT, Full-arch Restoration, posted April 29, 2026: accessdata.fda.gov/recall/219528
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