Straumann USA LLC recalls 7 Custom Abutment AS Ti for Straumann RC. The recall follows a material mix-up during manufacturing. A TAN material bar was incorrectly identified as Titanium Bar Ti Gr4 D, causing RC Titanium abutments to be made with TAN material. Stop using the device and contact Straumann for instructions immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Straumann USA LLC or your healthcare provider for instructions. Notification method: Letter
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Custom Abutments connect prosthetic components to dental implants in implant-supported restorations. They are usually fabricated to fit specific implant systems and patient anatomies.
A TAN material was used instead of Titanium Ti Gr4 D due to misidentification of the raw material. This could affect biocompatibility and mechanical performance of the abutments.
Not specified in the recall notice.
Only seven units are affected. The recall emphasizes strict material traceability in dental implant components and may prompt providers to verify inventory and supplier processes.
Consult the recall notice and the FDA enforcement page for the recall number Z-1633-2026.
The notice does not specify a timeline; follow manufacturer guidance and recall communications.
Keep the recall letter, model and lot numbers, and all correspondence with the manufacturer and healthcare provider
Catalog Number/Art.: 010.5438 UDI-DI: 07630031773937 Order numbers (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 Distribution: Worldwide; US states CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; Canada Units recalled: 7 Sold by: Straumann USA LLC Sold since: Unknown Price: Unknown
No injuries or incidents have been reported.
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