Device 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 applications Catalog Number: 5820-066-012
Z-0063-2025
Product summary
- Event
- Event 95342
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 307 units
- Official record key
device-enforcement:Z-0063-2025
Official wording
Reason: 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.
Code information: GTIN: 04546540362346 Lot number: 22329017
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Columbia.
Derived failure modes
-
Unknown
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.