CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report

Neuro Match Head recalled by Stryker

Stryker is recalling stryker Neuro Match Head, distributed nationwide in the US. The recall was initiated on 28 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 04546540467775, Lot Number 22174017

Quantity recalled464 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0981-2025
FDA event ID: 95998
Recalling firm: Stryker, Portage, MI
Classification: Class II
Status: Ongoing
Recall initiated: 28 Jun 2023
FDA classified: 17 Jan 2025
Reported: 29 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

28 Jun 2023	Recall initiated by company
17 Jan 2025	Classified by FDA	+569 days
29 Jan 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

Where it was distributed

Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.

Nationwide

Questions about this recall

Is Neuro Match Head recalled?

Yes. Stryker recalled Neuro Match Head on 28 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-0981-2025.

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).

Which lots are affected?

GTIN 04546540467775, Lot Number 22174017

Where was it sold?

Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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