Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    (01)07332747083866(10)818727 (01)07332747083866(10)818683 Catalog# 37481
  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:
Nobel Biocare Usa Llc
Reason for Recall:
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.

Product Codes/Lot Numbers:

(01)07332747083866(10)818727 (01)07332747083866(10)818683 Catalog# 37481

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1324-2020

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