🔍 RecallPedia

SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.

Class I - Dangerous
🏥 Medical Devices Recalled: May 23, 2023 TEI Biosciences Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Item No. (UDI-DI): 606-005-003 (10381780112952) and 606-005-004 (10381780112969).
  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:
TEI Biosciences, Inc.
Reason for Recall:
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.

Product Codes/Lot Numbers:

Item No. (UDI-DI): 606-005-003 (10381780112952) and 606-005-004 (10381780112969).

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2071-2023

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