stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530… recallZ-0982-2025 · Stryker Corporation · initiated Jun 28, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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).

FDA root cause category: Process control

What the company is doing

Stryker issued a Medical Device Recall notice to its consignees on 06/28/2024 via FedEx. The notice explained the issue and requested the following: "Actions to be taken 1. Review your inventory to locate and quarantine any affected products found on-hand. 2. Sign and return the enclosed Business Response Form (BRF), even if affected product is no longer in inventory, to the email [email protected]. 3. Upon receiving your Business Response Form to the email, [email protected], a shipping label will be provided to return any recalled product on-hand. 4. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Please contact Jordan Anderson at (269) 800-1347 or [email protected] with questions or concerns."

Recall details

Recall number: Z-0982-2025
Status: Open, Classified
Initiated by the company: Jun 28, 2023
Posted by the FDA: Jan 17, 2025
Recalling firm: Stryker Corporation
Quantity: 1489 units
Product code: HBE
FDA submissions: K143320
Distribution: Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.

Product description

stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery

Code information (models, lots, serial numbers)

GTIN 07613154028177, Lot Numbers: 22179047, 22179027, 22160017

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

NA 5820107530
Stryker Corporation · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
1 recall6 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 95998).

Z-0981-2025 · Open, Classified
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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