CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report
Neuro Match Head recalled by Stryker
Stryker is recalling 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
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.
Questions about this recall
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95998| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Precision Neuro Match Head recalled by Stryker | Stryker | Packaging Defects | Nationwide |
More recalls from Stryker
All 192| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pkg., Strykeflow Suction/irrigator Ps recalled by Stryker | Stryker | Packaging Defects | Nationwide |
| Device | CLASS II | Ahto Tube Set With Tip Packaging recalled by Stryker | Stryker | Packaging Defects | Nationwide |
| Device | CLASS II | Pkg., Single Spike Tube Set recalled by Stryker | Stryker | Packaging Defects | Nationwide |
| Device | CLASS II | Ahto Tube Set Packaging recalled by Stryker | Stryker | Packaging Defects | Nationwide |
| Device | CLASS II | Ahto Dual Spike Tube Set Packaging recalled by Stryker | Stryker | Packaging Defects | Nationwide |
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| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |