Z-0063-2025 Class II Ongoing
FDA device recall Z-0063-2025 was initiated by Stryker Corporation on Sep 5, 2024 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 307 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 23, 2024
- Initiation Date
- Sep 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 307 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Columbia.
Code Information
GTIN: 04546540362346 Lot number: 22329017
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0063-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026