Stryker Corporation: 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 procedur

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.

Details from the source

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: Worldwide distribution - US Nationwide and the countries of Canada, Columbia. Quantity: 307 units Lot/code info: GTIN: 04546540362346 Lot number: 22329017

UPC codes

04546540362346

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.