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.: 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 +1 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
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
- Verify Catalog Number/Art. 010.5438
- 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
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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
- Worldwide distribution including 10 US states and Canada
- Material mix-up involving TAN material misidentified as Titanium Ti Gr4 D
- No injuries reported
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