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Unrated Medical device recall · FDA · Published March 17, 2026

Straumann Custom Abutment Ti Recall: Material Mix-Up Risk

Straumann recalls Custom Abutment Ti products (Catalog 027.4620) due to manufacturing error using incorrect material. Affected items may have safety risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1632-2026Medical deviceStraumann ›
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Contact the company

Recalling firmStraumann USA LLC60 Minuteman Rd · Andover, MA 01810-1008
✎ GovInfoNow plain-language explainer

Straumann is recalling Custom Abutment Ti products (Catalog Number 027.4620) because a manufacturing error used TAN material instead of titanium. This could lead to improper dental implants if used in dental procedures. Read more at govinfonow.com/recall/49711-straumann-custom-abutment-ti-recall-material-mix-up-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/49711-straumann-custom-abutment-ti-recall-material-mix-up-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1632-2026

Cite this page

“Straumann Custom Abutment Ti Recall: Material Mix-Up Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49711-straumann-custom-abutment-ti-recall-material-mix-up-risk. Based on FDA recall #Z-1632-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1632-2026%22&limit=1).

Straumann USA LLC, with FDA assistance, recalled Custom Abutment Ti units due to a manufacturing material mix-up. The Food and Drug Administration announced the recall on March 17, 2026.

How to tell if you have it

  • Brand: Straumann
  • Product: Custom Abutment Ti, for Straumann RC, incl. TAN screw
  • Catalog Number/Art.: 027.4620
  • UDI-DI: 07630031713766
  • Lot codes: 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

The hazard

A raw material bar of TAN-material was incorrectly identified as a Titanium Bar Ti Gr4 during manufacturing. This resulted in RC Titanium abutments being produced using the wrong material on Mill-from-Bar Machine 396-06.

Context

GovInfoNow's records show Straumann USA LLC has 13 other recalls on record since May 27, 2021. Other recent recalls of similar products include the Straumann GM Helix Dental Implant Recall (July 13, 2026) and the Straumann Bone Level Tapered Implant Recall (July 16, 2026).

How to tell if you have this one

Check for the Catalog Number 027.4620 on the product. The affected items include specific order numbers listed in the recall notice.

  • Brand
    Straumann
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.
Recall numberProduct, codes & lotsQuantity
Z-1632-2026Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;; Catalog Number/Art.: 027.4620; UDI-DI: 07630031713766; Order number (lot): 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;13 units
Z-1633-2026Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;; Catalog Number/Art.: 010.5438; UDI-DI: 07630031773937; Order number (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;7 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the Catalog Number 027.4620 on the product or order documentation.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 10 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Florida, Illinois, Iowa, Minnesota, Missouri, Montana, Oregon, Washington.

Recall timeline

FDA published this recall 15 days after the firm started it.

1. Firm started the recall: Mar 17, 202612. FDA classified it Class II: Mar 24, 202623. Published in FDA’s Enforcement Report: Apr 1, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1632-2026 (March 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1632-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA