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Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
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Straumann USA Recalls Impression Caps Over Mix-Up Hazard
Straumann USA recalled 561 units of its Impression Post Closed Tray on January 6, 2026. The recall occurred due to a mix-up where impression caps were mistakenly packaged in magenta instead of the intended brown. Healthcare providers and patients must stop using the device immediately.
Quick Facts at a Glance
- Recall Date
- January 6, 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
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
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
The WB Impression Post Closed Tray is used in dental procedures to create accurate impressions for crowns, bridges, and other dental restorations. Consumers purchase this product for its reliability in producing high-quality dental impressions.
Why This Is Dangerous
The impression caps provided in the package were incorrectly mixed up, with magenta caps instead of brown. This mix-up can lead to errors in dental procedures, impacting treatment outcomes.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers who have purchased this product face potential safety risks if they do not stop using the recalled caps. The inconvenience of returning the product and obtaining a replacement may also affect dental practices.
Practical Guidance
How to identify if yours is affected
- Check the package for the article number 065.4810.
- Look for lot numbers VWPX4 or VWPX6 on the product packaging.
- Verify the color of the impression caps—magenta caps are part of the recall.
Where to find product info
You can find the article number and lot numbers printed on the product packaging or inside the box.
What timeline to expect
Expect a response from the manufacturer within 4-6 weeks for processing refunds or replacements.
If the manufacturer is unresponsive
- Document your contact attempts with the manufacturer.
- Reach out to your healthcare provider for assistance.
- Consider filing a complaint with the FDA if you do not receive a timely response.
How to prevent similar issues
- When purchasing medical devices, check for proper certifications and reviews.
- Confirm product details with your healthcare provider before use.
- Stay informed about recall notices for medical products.
Documentation advice
Keep a record of your purchase receipt, any correspondence with the manufacturer, and photos of the product for your records.
Product Details
The recalled product is the WB Impression Post Closed Tray with guide screw, L 13mm, TAN/POM. It was distributed nationwide in the US. The article number is 065.4810, and the affected lot numbers are VWPX4 and VWPX6.
Key Facts
- 561 units recalled
- Class III medical device
- Mixed-up impression caps
- Stop using the device immediately
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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 TypeImpression Cap
Sold At
Multiple Retailers
Product Details
Brand
Categories
Model Numbers
Article Number: 065.4810
UDI-DI: 07630031741110
Lot numbers: VWPX4
VWPX6
Affected States
ALL
Report Date
February 18, 2026
Source Agency
FDA - Medical DevicesRecall Status
ACTIVE
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