Z-0981-2025 Class II Ongoing
FDA device recall Z-0981-2025 was initiated by Stryker Corporation on June 28, 2023 and is designated Class II. Reason for recall: 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). The recall status is ongoing. Affected quantity: 464 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2025
- Initiation Date
- June 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 464 units
Product Description
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Reason for Recall
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).
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.
Code Information
GTIN 04546540467775, Lot Number 22174017