Stryker Corporation: Medical Device Recall in 2025 - (Recall #: Z-0980-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 28, 2023

Date Posted: January 29, 2025

Recall Number: Z-0980-2025

Event ID: 95996

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).

Status: Ongoing

Product Quantity: 491 devices

Code Information:

GTIN 04546540362483, Lot Number 21341057

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.

Voluntary or Mandated:

Voluntary: Firm initiated