HIGH

Straumann USA Recalls 7 Custom Abutment AS Ti for Straumann RC Over TAN Material (2026)

Straumann USA LLC recalls 7 Custom Abutment AS Ti for Straumann RC. The recall follows a material mix-up during manufacturing. A TAN material bar was incorrectly identified as Titanium Bar Ti Gr4 D, causing RC Titanium abutments to be made with TAN material. Stop using the device and contact Straumann for instructions immediately.

Quick Facts at a Glance

Recall Date
March 17, 2026
Hazard Level
HIGH
Brand
Straumann USA
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

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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About This Product

Custom Abutments connect prosthetic components to dental implants in implant-supported restorations. They are usually fabricated to fit specific implant systems and patient anatomies.

Why This Is Dangerous

A TAN material was used instead of Titanium Ti Gr4 D due to misidentification of the raw material. This could affect biocompatibility and mechanical performance of the abutments.

Industry Context

Not specified in the recall notice.

Real-World Impact

Only seven units are affected. The recall emphasizes strict material traceability in dental implant components and may prompt providers to verify inventory and supplier processes.

Practical Guidance

How to identify if yours is affected

  1. Verify Catalog Number/Art. 010.5438
  2. Check UDI-DI 07630031773937
  3. Review lot/order numbers listed (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)
  4. Confirm if you received a Straumann RC abutment that may have TAN material

Where to find product info

Consult the recall notice and the FDA enforcement page for the recall number Z-1633-2026.

What timeline to expect

The notice does not specify a timeline; follow manufacturer guidance and recall communications.

If the manufacturer is unresponsive

  • Escalate with your healthcare provider
  • Consider contacting regulatory authorities if the manufacturer is unresponsive
  • Document all communications and responses

How to prevent similar issues

  • Implement stringent material identification and lot-traceability processes
  • Verify material composition before use in implant components
  • Maintain updated supplier communications and batch records

Documentation advice

Keep the recall letter, model and lot numbers, and all correspondence with the manufacturer and healthcare provider

Product Details

Catalog Number/Art.: 010.5438 UDI-DI: 07630031773937 Order numbers (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 Distribution: Worldwide; US states CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; Canada Units recalled: 7 Sold by: Straumann USA LLC Sold since: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 7 recalled units
  • Catalog 010.5438
  • UDI-DI 07630031773937
  • Worldwide distribution including 10 US states and Canada
  • Material mix-up involving TAN material misidentified as Titanium Ti Gr4 D
  • No injuries reported
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeDental Implant Abutment
Sold At
Multiple Retailers

Product Details

Model Numbers
Catalog Number/Art.: 010.5438
UDI-DI: 07630031773937
Order number (lot): 71315US_00729_01_b00
91076US_03269_00_b00
72509US_01048_00_b00
+4 more
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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