Stryker 1.2mm Cross Cut Fissure Recalled for Endotoxin Levels
Stryker is recalling 307 units of 1.2mm Cross Cut Fissure saw blades due to potential endotoxin levels exceeding 2.15 EU/device, which may cause fever, inflammation, or meningitis.
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: The recall involves a medical device with a risk of harm (fever, inflammation, meningitis) where specific injuries or illnesses have not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Corporation is recalling 307 units of the 1.2mm Cross Cut Fissure saw blade (Catalog Number 5820-066-012, Lot Number 22329017). The product is intended for use in cutting, drilling, reaming, decorticating, shaping, and smoothing bone, bone cement, and teeth in various surgical procedures, including dental, ENT, neuro, spine, and endoscopic applications.
The recall is issued because the devices may exhibit endotoxin levels greater than 2.15 EU/device. Exposure to endotoxin at these levels may result in fever and inflammation. Meningitis may occur if the endotoxin comes into contact with cerebrospinal fluid, making patients undergoing neurosurgical or spinal procedures the population at greatest risk.
The affected units were distributed worldwide, including the United States, Canada, and Colombia. Healthcare providers and consumers should stop using the affected devices and contact Stryker Corporation for further instructions or a return.
The recalled product
- Product
- 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic appl
- Manufacturer
- Stryker Corporation
- Affected units
- 307
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 (1)
- GTIN: 04546540362346 Lot number: 22329017
Distribution
Distributed nationwide across the United States.
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