Straumann USA recalled 13 Custom Abutment Ti RC units distributed worldwide, including the United States and Canada. A TAN material was misidentified as Titanium Ti Gr4 D during manufacturing, causing RC Titanium abutments to be made from TAN material. Clinics and patients should stop using the devices immediately and follow recall instructions from Straumann USA or their healthcare providers.
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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These abutments are custom titanium components used in dental implants to connect the prosthetic crown to the implant. They are sold worldwide to clinics and patients through authorized distributors.
A material mix-up caused some RC Titanium abutments to be manufactured with TAN material instead of Titanium Ti Gr4 D, which could affect performance or biocompatibility.
This recall is not described as part of a broader safety pattern in the supplied data.
The risk is primarily operational and device integrity related. The recall urges immediate discontinuation of affected units to prevent potential implant complications.
Official recall notices online, including the FDA recall page and Straumann communications.
Replacement or remediation details will be provided by Straumann USA LLC; customers should await instructions and may receive further guidance.
Keep copy of recall letter, product packaging, serial numbers, and all communications with Straumann or clinicians; document dates and actions taken
Catalog Number/Art.: 027.4620; UDI-DI: 07630031713766; Lot numbers: 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; Quantity: 13 units; Sold worldwide with US distribution in CA, CO, FL, IA, IL, MN, MO, MT, OR, WA and Canada; Recall Date: 2026-03-17; Report Date: 2026-04-01; Status: ACTIVE; Brand: Straumann USA; Categories: Health & Personal Care; Medical De v
No injuries or incidents have been reported.
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