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Recall Observatory FDA recall evidence

Device product

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

Z-0982-2025

June 28, 2023

Class II

Product summary

Firm
Stryker Corporation
Event
Event 95998
Status
Ongoing
Classification
Class II
Quantity
1489 units
Official record key
device-enforcement:Z-0982-2025

Official wording

Reason: 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).

Code information: GTIN 07613154028177, Lot Numbers: 22179047, 22179027, 22160017

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).