Stryker neurosurgical device labeling mismatch: wrong instruments shipped
Stryker is recalling 3.0MM Neuro Match Head devices (REF 5820-107-430) where the actual device may not match the product label, potentially causing surgeons to use wrong instruments during neurosurgery.
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: FDA Class II recall of neurosurgical device with labeling mismatch creating risk of incorrect instrument use during surgery. Per the severity rubric, risk-of-harm medical devices where injury has not yet been reported receive a High severity score.
Plain-English summary
Stryker Corporation has recalled its 3.0MM Neuro Match Head surgical device (REF 5820-107-430, GTIN 04546540467775), used to cut bone and bone cement during neurosurgery. The recall affects 464 units from Lot Number 22174017 with worldwide distribution including the United States, United Kingdom, Netherlands, and New Zealand.
The issue is that the device inside the package may not match the product information on the outer label. For example, a package labeled as model 5820-107-430 may actually contain a different model such as 5820-107-530, or vice versa. This mismatch creates potential for incorrect instrument use during surgical procedures.
No injuries or illnesses have been reported in connection with this issue. The recall was issued as a Class II medical device recall by the FDA.
The recalled product
- Product
- stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
- Manufacturer
- Stryker Corporation
- Hazard
- device-mismatch
- labeling-error
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 (2)
- GTIN 04546540467775
- Lot Number 22174017
Distribution
Distributed nationwide across the United States.
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