Home / Recalls / Medical Devices
Stryker Instruments Div. of Stryker Corporation recalls Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes
Recalled November 13, 2013 · FDA recall Z-0127-2014 · Stryker Instruments Div. of Stryker
Hazard
Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of m · FDA Class II
Units
20,385 total distributed since 2004
Sold at
Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.
Description
Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of m
Product
Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.
Manufacturer(s)
Stryker Instruments Div. of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →