Straumann USA LLC: Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
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 Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
- 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.: 027.4620; UDI-DI: 07630031713766; Order number (lot): 92465US_12039_00_b00 , 92465US_12040_00_b00 , 92465US_12047_00_b00 , 92465US_12048_00_b00 , 70959US_02227_00_b00 , 94021US_02348_00_b00, 70416US_07543_00_b00 , 91395US_01687_00_b00 , 91545US_03284_00_b00 , 91545US_03285_00_b00 , 71711US_00420_00_b00 , 91853US_06313_00_b00 , 72747US_00247_00_b00;
- Product quantity
- 13 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Andover
- State
- MA
- Country
- United States
- Event id
- 98565
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