FDA DevicesClass II
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: ...
Published: April 1, 2026Recall ID: Z-1633-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Affected Products
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Additional Source Details
| Field | Value |
|---|---|
| City | Andover |
| State | MA |
| Event id | 98565 |
| Address 1 | 60 Minuteman Rd |
| 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; |
| Postal code | 01810-1008 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 7 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260317 |
| Initial firm notification | Letter |
| Center classification date | 20260324 |
Overview
- Recalling FirmStraumann USA LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.