Use cautionMedical device recall · FDA · Published June 28, 2023
Stryker 3.0MM Neuro Match Head Recall: Package Label Mismatch Risk
Stryker recalls 3.0MM Neuro Match Heads with potential label mismatch between package and outer label, risking incorrect surgical device use during neurosurgery.
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).
Take action
Contact the company
📍Recalling firmStryker Corporation1941 Stryker Way · Portage, MI 49002-9711
“Stryker 3.0MM Neuro Match Head Recall: Package Label Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57768-stryker-3-0mm-neuro-match-head-recall-package-label-mismatch. Based on FDA recall #Z-0981-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0981-2025%22&limit=1).
The FDA announced on June 28, 2023, that Stryker Corporation voluntarily recalled stryker 3.0MM Neuro Match Head devices due to potential mismatch between the device inside the package and the outer label. The agency issued recall number Z-0981-2025 for the Class II device distributed worldwide.
How to tell if you have it
stryker 3.0MM Neuro Match Head, REF 5820-107-430
UPC 04546540467775
Lot Number 22174017
The hazard
According to the FDA, there is potential the device inside the package may not match the product information on the outer label. For example, the label may state REF 5820-107-430 but the package contains a 5820-107-530 device or vice versa.
Context
GovInfoNow's records show Stryker Corporation has 34 other recalls on record since November 17, 2017. Recent Stryker recalls include a June 8, 2026 recall for leaking handpieces and a May 6, 2026 recall for an electrical shock risk in the Neptune Smart Docking Station. Other recent recalls of similar products include the July 13, 2026 Straumann GM Helix Dental Implant Recall for packaging mismatch risk, the December 19, 2025 Tornier Perip Screw Recall for incorrect labeling, and the January 5, 2026 Encore Medical EMPOWR Acetabular System Recall for packaging discrepancy.
How to tell if you have this one
Check for the product code 5820-107-430 on the outer label and the package. The device was sold with GTIN 04546540467775 and Lot Number 22174017.
Brand
Stryker
Product
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.
Recall number
Product, codes & lots
Quantity
Z-0981-2025
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery; GTIN 04546540467775, Lot Number 22174017
464 units
Z-0982-2025
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery; GTIN 07613154028177, Lot Numbers: 22179047, 22179027, 22160017
1489 units
Based on the official FDA remedy
What to do — step by step
Check Package Label
Compare the product code on the outer label with the package to ensure they match (e.g., 5820-107-430 vs. 5820-107-530).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0981-2025 (June 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0981-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.