HIGHFDA DEVICE

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.

Official notice
Straumann USAHealth & Personal CareMedical DevicesArticle Number: 065.4810UDI-DI: 07630031741110Lot numbers: VWPX4

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 6, 2026
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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
Impression Cap
Model numbers
Article Number: 065.4810, UDI-DI: 07630031741110, Lot numbers: VWPX4, VWPX6
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 6, 2026

  2. Reported by FDA DEVICE

    February 18, 2026

  3. RecallRadar source check

    February 25, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

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

  1. Check the package for the article number 065.4810.
  2. Look for lot numbers VWPX4 or VWPX6 on the product packaging.
  3. 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.

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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

  • Class III medical device
  • Mixed-up impression caps
  • Stop using the device immediately

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

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

Product Classification

Product Details

Model Numbers
Article Number: 065.4810
UDI-DI: 07630031741110
Lot numbers: VWPX4
VWPX6
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

Related Recalls