Reported Oct 23, 2024 · Ongoing
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of…
Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Corporation · 1941 Stryker Way · Portage, MI · 49002-9711
Is this the product you have?
- 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 applications Catalog Number5820-066-012
- Lot codes and dates
- GTIN04546540362346
- Lot number22329017
- Amount recalled
- 307 units
Where it was sold
- Nationwide
Why it was recalled
May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.
This product could cause temporary or reversible health problems — stop using it.
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