Z-0980-2025Class II

The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement...

Name: Z-0980-2025 The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement...
Creator: Stryker Corporation
Published: 2023-06-28
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2023-06-28 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Corporation began a recall of The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and... on 2023-06-28. FDA classified it as Class II and gives the reason as "There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0980-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-28
Posted: 2025-01-17
Recalling firm: Stryker Corp.
Product: The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. The 3.0MM Prec Neuro Match Head bur (5820-107-530) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. These burs are sold as single use devices without their own IFU.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
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 5820-107-030 but package contains a 5820-107-530 device).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 be taken: "1. Review your inventory to locate and quarantine any affected products found on-hand. 2. Sign and return the enclosed Business Reply Form (BRF), even if affected product is no longer in inventory, to the email [email protected]. 3. Upon receiving your Business Reply 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."
Quantity in commerce: 491 devices
Distribution: Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.
Product codes and lots: GTIN 04546540362483, Lot Number 21341057

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0980-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0980-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17

Product code HBE

K143320Class IIStryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp. / cleared 2015-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)