FDA recall, , Moderate risk
Straumann Custom Abutments
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments.
Summary by Recall Canary from the FDA notice
What happened
Straumann USA LLC, of Andover, Massachusetts, began a recall on March 17, 2026, of Custom Abutment Ti and Custom Abutment AS Ti products because a material mix-up occurred during manufacturing. A raw material bar of TAN-material was incorrectly identified as a Titanium Bar Ti Gr4 D, and RC Titanium abutments were manufactured using the TAN bar material on Mill-from-Bar Machine 396-06.
The recall was added to the FDA's Enforcement Report on March 24, 2026, and classified that same day. Distribution was worldwide, including US nationwide distribution in California, Colorado, Florida, Iowa, Illinois, Minnesota, Missouri, Montana, Oregon, and Washington, and the country of Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
- UDI-DI
- 07630031713766
- Lot code
- 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
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
- UDI-DI
- 07630031773937
- Lot code
- 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
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of California, Colorado, Florida, Iowa, Illinois, Minnesota, Missouri, Montana, Oregon, Washington; and the country of Canada.
- Company
- Straumann USA LLCAndover, Massachusetts
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98565
- Recall numbers
- Z-1632-2026 to Z-1633-2026
All recalls from Straumann USA LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
