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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Straumann USA
- Product type
- Dental Implant Abutment
- 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, 92465US_12048_00_b00, 70959US_02227_00_b00, 94021US_02348_00_b00 +7 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 17, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US states CA, CO, FL, IA, IL, MN, MO, MT, OR, WA and Canada
- 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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