HIGH
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Includes an incorrect screw seat interface.
Straumann USA
Includes an
HIGH
Straumann USA Recalls 13 Custom Abutment Ti RC for TAN Material Mix-Up (2026)
Straumann USA recalled 13 Custom Abutment Ti RC units distributed worldwide, including the United States and Canada. A TAN material was misidentified as Titanium Ti Gr4 D during manufacturing, causing RC Titanium abutments to be made from TAN material. Clinics and patients should stop using the devices immediately and follow recall instructions from Straumann USA or their healthcare providers.
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
These abutments are custom titanium components used in dental implants to connect the prosthetic crown to the implant. They are sold worldwide to clinics and patients through authorized distributors.
Why This Is Dangerous
A material mix-up caused some RC Titanium abutments to be manufactured with TAN material instead of Titanium Ti Gr4 D, which could affect performance or biocompatibility.
Industry Context
This recall is not described as part of a broader safety pattern in the supplied data.
Real-World Impact
The risk is primarily operational and device integrity related. The recall urges immediate discontinuation of affected units to prevent potential implant complications.
Practical Guidance
How to identify if yours is affected
- 1) Check if you own Catalog 027.4620 abutments.
- 2) Review the lot numbers against the list provided in the recall.
- 3) Verify the UDI 07630031713766 for affected devices.
- 4) If any match, stop use and contact Straumann USA LLC for instructions.
Where to find product info
Official recall notices online, including the FDA recall page and Straumann communications.
What timeline to expect
Replacement or remediation details will be provided by Straumann USA LLC; customers should await instructions and may receive further guidance.
If the manufacturer is unresponsive
- Escalate to the regulatory body overseeing medical devices in your country
- File a formal complaint with Straumann USA LLC and seek guidance from your clinician
How to prevent similar issues
- Verify material traceability in future implants
- Work only with authorized Straumann distributors
- Request documentation on material origin and lot-level traceability
- Keep a record of all recall communications and confirmations of actions taken
Documentation advice
Keep copy of recall letter, product packaging, serial numbers, and all communications with Straumann or clinicians; document dates and actions taken
Product Details
Catalog Number/Art.: 027.4620; UDI-DI: 07630031713766; Lot numbers: 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; Sold worldwide with US distribution in CA, CO, FL, IA, IL, MN, MO, MT, OR, WA and Canada; Recall Date: 2026-03-17; Report Date: 2026-04-01; Status: ACTIVE; Brand: Straumann USA; Categories: Health & Personal Care; Medical De v
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 13 units recalled
- Worldwide distribution including US states CA, CO, FL, IA, IL, MN, MO, MT, OR, WA and Canada
- Catalog 027.4620; UDI-DI 07630031713766
- Lot numbers include 92465US_12039_00_b00 and others
- Recall date 2026-03-17; Report date 2026-04-01
- High hazard level; Class II recall
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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
Tags
Sold At
Multiple Retailers
Product Details
Brand
Categories
Model Numbers
Catalog Number/Art.: 027.4620
UDI-DI: 07630031713766
Order number (lot): 92465US_12039_00_b00
92465US_12040_00_b00
92465US_12047_00_b00
+10 more
Affected States
ALL
Report Date
April 1, 2026
Source Agency
FDA - Medical DevicesRecall Status
ACTIVE
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