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Recall Observatory FDA recall evidence

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

September 05, 2024

Class II

Product summary

Firm
Stryker Corporation
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

    reason.no_named_rule · v1.0.0

    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.