Stryker Corporation recalls 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of b…

Recall date

September 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0063-2025

FDA classification

Class II

Brand / firm

Stryker Corporation

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Canada, Columbia.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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