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).
Stryker is recalling a specific neurosurgical tool that may have a mismatch between the package and outer label. This could lead to using the wrong device during surgery, which is serious for patients.
The device might be labeled incorrectly in the package versus the outer label. This mismatch could mean the wrong size or type of surgical tool is used during neurosurgery, potentially causing complications.
Surgical teams using the recalled 3.0MM Neuro Match Head during neurosurgery are most at risk. Patients undergoing procedures with this device could face incorrect surgical tool use.
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.
Compare the product code on the outer label with the package to ensure they match (e.g., 5820-107-430 vs. 5820-107-530).
The recall is due to potential mismatch between the package and outer label, which could lead to using the wrong surgical device during neurosurgery.
The product code is 5820-107-430, with GTIN 04546540467775 and Lot Number 22174017.
Check the outer label for product code 5820-107-430 and verify it matches the package label.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0981-2025 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0981-2025 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.