Straumann USA LLC: Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Straumann USA LLC
- Product
- Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
- Reason / hazard
- A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.
- Recall initiated
- 2026-03-17
- Code info
- Catalog Number/Art.: 010.5438; UDI-DI: 07630031773937; Order number (lot): 71315US_00729_01_b00, 91076US_03269_00_b00, 72509US_01048_00_b00, 72839US_00065_00_b00, 39133US_11508_02_b00, 4202CA_00558_00_b00, 72630CA_00109_00_b00;
- Product quantity
- 7 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Andover
- State
- MA
- Country
- United States
- Event id
- 98565
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