HIGH

Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments

Includes an incorrect screw seat interface.

Quick Facts at a Glance

Recall Date
March 27, 2026
Hazard Level
HIGH
Brand
Straumann USA
Geographic Scope
8 states

Hazard Information

Includes an incorrect screw seat interface.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Straumann USA LLC or your healthcare provider for instructions. Notification method: Letter

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Full Description

Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments. Reason: Includes an incorrect screw seat interface.. Classification: Class II. Quantity: 6 units. Distribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
Article 010.0158. UDI: (01)07630031759764(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00622_00_b00
28000US_00431_00_b00
28000US_00489_00_b00
28000US_00792_00_b00
28000US_00908_00_b00
+1 more
Affected States
AL, AZ, FL, HI, LA, MD, OH, VA
Report Date
May 6, 2026
Recall Status
ACTIVE

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