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Open, Classified

Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

FDA Recall Z-1994-2026 · Posted 2026-04-29

Recalling FirmStraumann USA LLC
Recall StatusOpen, Classified
Product CodeNHA
Date Initiated2026-03-27
Product Quantity5 units

Reason for Recall

Includes an incorrect screw seat interface.

Firm Action

Straumann USA notified consignees on about 03/27/2026 via telephone call, mailed letter, or email. Consignees were instructed to examine inventory for affected product, cease use and quarantine any affected units on hand, arrange for the return of all affected units and complete and return the provided Customer Confirmation Form. Consignees were also instructed to no contact Straumann contact Jennifer Jackson to organize a remake of the units, if any were used. Once the new restoration is available, schedule the patient to replace the restoration.

Root Cause

Under Investigation by firm

Distribution Pattern

US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A. · 2024-12-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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