FDA Medical devices recall ·
stryker 3.0MM Neuro Match Head recall
- Recall number
- Z-0981-2025
- Date
- (initiated June 28, 2023)
- Company / brand
- Stryker Corporation
1941 Stryker Way, Portage, MI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 464 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN 04546540467775, Lot Number 22174017
Distribution
Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0981-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.