FDAFDA · Food and drugs·Recall number Z-0982-2025
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
Published January 29, 2025 · Recall initiated: June 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Corporation
- Distributor
- Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.
- Lot
- GTIN 07613154028177, Lot Numbers: 22179047, 22179027, 22160017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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