Stryker 3.0MM Neuro Precision Head Recalled for Package Labeling Mismatch
Stryker is recalling the 3.0MM Precision Neuro Match Head due to a packaging discrepancy where the device may not match the product label. Approximately 1,489 units distributed worldwide are affected, including lot numbers 22179047, 22179027, and 22160017.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical device with a labeling mismatch that could result in the use of an incorrect instrument in neurosurgery. No injuries or hospitalizations have been reported to date, making this a theoretical risk-of-harm situation rather than an active injury event, consistent with the rubric criterion for a High severity rating.
Plain-English summary
Stryker Corporation is recalling the 3.0MM Precision Neuro Match Head (REF 5820-107-530), a surgical instrument used to cut bone and bone cement during neurosurgery. The recall was initiated because the device contained in the package may not match the product information on the outer label. For instance, the label might state that the device is model 5820-107-430, while the actual contents are model 5820-107-530, or vice versa.
The recall affects 1,489 units distributed worldwide, including throughout the United States, United Kingdom, Netherlands, and New Zealand. The affected lot numbers are 22179047, 22179027, and 22160017 (GTIN 07613154028177). The U.S. Food and Drug Administration classified this as a Class II recall.
Healthcare providers should verify that the device model in hand matches the product label before use in surgical procedures. If a mismatch is identified, healthcare facilities should contact Stryker Corporation to report the discrepancy and receive further guidance.
The recalled product
- Product
- stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
- Manufacturer
- Stryker Corporation
- Hazard
- mislabeling
- product-mix-up
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- GTIN 07613154028177
- Lot Numbers: 22179047
- 22179027
- 22160017
Distribution
Distributed nationwide across the United States.
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