HIGH

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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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.

The Hazard

The mix-up of impression caps poses a risk to patients and healthcare providers. The incorrect color of the caps may lead to misidentification during dental procedures.

Reported Incidents

No injuries or incidents have been reported in connection with this recall. The risk level is classified as high due to potential misuse.

What to Do

Stop using the device immediately. Contact Straumann USA LLC or your healthcare provider for further instructions. Follow the recall instructions provided by the manufacturer.

Contact Information

For further information, contact Straumann USA LLC at their customer service number or visit their website. Notification was sent via letter to affected parties.

Key Facts

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

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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

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