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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Stryker Leibinger GmbH & Co. KG: Cranial Skeleton Mesh Recalled Due to Mislabeled Packaging

Agency Publication Date: May 8, 2024
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Summary

Stryker Leibinger GmbH & Co. KG is recalling 63 units of the Stryker 1,5/1,7MM Dynamic Mesh (Standard-Medium) used for cranial skeleton reconstruction. The product, which is intended for stabilizing bony areas of the skull, was packaged in boxes labeled as 'Gold Mesh' (product 56-90614) but actually contains 'Blue Mesh' (product 56-90314). Consumers and medical facilities should contact their healthcare provider or the manufacturer to address the mislabeled units.

Risk

The use of the incorrect mesh type during a surgical procedure can cause unexpected delays while the correct product is sourced, potentially increasing the time a patient is under anesthesia.

What You Should Do

  1. Identify if you have the affected Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM by checking the packaging for Catalog Number 56-90614.
  2. Check the box for GTIN 07613327123197 and Lot Number 270644 to confirm if the unit is part of this recall.
  3. Inspect the product inside the packaging; if the box is labeled as 56-90614 (Gold Mesh) but contains 56-90314 (Blue Mesh), do not use it for surgery.
  4. Contact Stryker Leibinger GmbH & Co. KG or your healthcare provider for instructions on returning the mislabeled product and obtaining a replacement.
  5. For additional questions or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and coordination

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM
Model / REF:
56-90614
56-90314
UPC Codes:
07613327123197
Lot Numbers:
270644

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94367
Status: Active
Manufacturer: Stryker Leibinger GmbH & Co. KG
Sold By: Medical distributors; Direct hospital sales
Manufactured In: Germany
Units Affected: 63 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.