FDAFDA · Food and drugs·Recall number Z-0063-2025
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
Published October 23, 2024 · Recall initiated: September 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Corporation
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Columbia.
- Lot
- GTIN: 04546540362346 Lot number: 22329017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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