Home / Recalls / Straumann USA LLC / Z-1995-2026

Z-1995-2026 Class II Ongoing

Recalled by Straumann USA LLC — Andover, MA

Recall Details

Product Type
Devices
Report Date
May 6, 2026
Initiation Date
March 27, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

Product Description

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

Reason for Recall

Includes an incorrect screw seat interface.

Distribution Pattern

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

Code Information

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.

Other recalls by Straumann USA LLC

  • Z-1994-2026 Class II — Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.03 (March 27, 2026)
  • Z-1632-2026 Class II — Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027 (March 17, 2026)
  • Z-1633-2026 Class II — Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: (March 17, 2026)
  • Z-1337-2026 Class III — WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM (January 6, 2026)
  • Z-0582-2026 Class II — Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; (October 17, 2025)
  • Z-1862-2025 Class II — GM Helix Acqua Implant, Article Number: 140.984 (May 1, 2025)
  • Z-1863-2025 Class II — GM Helix Acqua Implant, Article Number: 140.985 (May 1, 2025)
  • Z-1671-2025 Class II — WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. (April 17, 2025)
  • Z-1861-2025 Class II — Plus Initial Drill, Article Number: 103.170; (April 14, 2025)
  • Z-1561-2025 Class II — TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; (March 8, 2025)