FDA-Device2013-11-13Class II
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.
Stryker Instruments Div. of Stryker Corporation
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
Sold states
Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.
Affected count
20,385 total distributed since 2004
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0127-2014Don't want to check this manually?
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