Straumann recalls Custom Abutment AS Ti for Straumann RC with TAN screw due to manufacturing mix-up using incorrect material. Affected units have specific catalog numbers and order numbers.
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.
Straumann is recalling Custom Abutment AS Ti for Straumann RC products that were made with the wrong material. This mix-up could lead to improper dental implants if used in dental procedures.
The recall involves a manufacturing mix-up where a TAN material bar was incorrectly labeled as a titanium bar. This means the dental implants could be made from the wrong material, potentially causing improper fit or failure during dental procedures.
Dental professionals who own or use the recalled Custom Abutment AS Ti for Straumann RC products are affected. Patients receiving dental implants with these products may be at risk.
Check for catalog number 010.5438 or order numbers listed in the recall notice. The affected products include specific UDI-DI codes and order numbers provided in the recall details.
Review the catalog number and order numbers listed in the recall notice to confirm if your product is affected.
The recall is due to a manufacturing mix-up where a TAN material bar was incorrectly identified as a titanium bar, leading to potential use of the wrong material in dental implants.
Check the catalog number and order numbers listed in the recall notice to see if your product is affected. If it is, contact Straumann USA LLC for further instructions.
The recall indicates a material mix-up that could lead to improper dental implants, but the official notice does not specify injury risks or remedies.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-1633-2026 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-1633-2026 from Straumann. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
