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Straumann Custom Abutment Ti
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MEDICAL DEVICE RECALLMODERATE

Straumann Custom Abutment Ti

Straumann recalls Custom Abutment Ti for Straumann RC due to material mix-up.

What to do

If you have a Custom Abutment Ti for Straumann RC, check the catalog number 027.4620 and the lot numbers on the packaging. Contact Straumann USA LLC for instructions on returning the affected product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-1632-2026
Agency
FDA
Firm
Straumann USA LLC
Recall ID
98565
Status
ONGOING

Why it was recalled

Straumann USA LLC is recalling Custom Abutment Ti for Straumann RC, including the TAN screw, because a material mix-up during manufacturing resulted in RC Titanium abutments being made from TAN material instead of titanium. The affected abutments may not meet material specifications, potentially affecting performance.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;Z-1632-202607630031713766
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;Z-1633-202607630031773937

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other recent recalls from Straumann USA LLC

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification