Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lots: 278735, & 278402/UDI:
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Preat Corp
Reason for Recall:
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only

Product Codes/Lot Numbers:

Lots: 278735, & 278402/UDI:

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2107-2025

Related Recalls

Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.

Apr 2, 2025 Implants & Prosthetics Nationwide View Details →

Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.

Jun 25, 2024 Other Medical Devices Nationwide View Details →