🔍 RecallPedia

DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.

Class I - Dangerous
🏥 Medical Devices Recalled: April 1, 2021 Stryker Leibinger GmbH & Co. KG Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot: DI20311,DI20307 Product Code (UDI): 07613327123265
  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:
Stryker Leibinger GmbH & Co. KG
Reason for Recall:
Inability for the user to inject the paste from the syringe into the target location.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.

Product Codes/Lot Numbers:

Lot: DI20311,DI20307 Product Code (UDI): 07613327123265

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1436-2021

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Stryker Leibinger GmbH & Co. KG

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