RecallRadar

FDA Device recall Z-1995-2026

Straumann n!ce Zr, HT, Full-arch Restoration

On 2026-05-06 the FDA classified a Class II recall of Straumann n!ce Zr, HT, Full-arch Restoration by Straumann Usa, citing includes an incorrect screw seat interface.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1995-2026
ClassificationClass II
Statusongoing
Initiated2026-03-27
Published2026-05-06
Last updated2026-09-13 11:58 UTC
CompanyStraumann Usa
DistributionAL, AZ, FL, HI, LA, MD, OH, VA

Product

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

Reason

Includes an incorrect screw seat interface.

Identifiers

code_info
Article 010.0158. UDI: (01)07630031759764(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00622_00_b00, 28000US_00431_00_b…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, 28000US_00908_01_b00.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1995-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.