FDA-Device2015-07-15Class II
Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Hazard
The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile, distributed by DePuy Spine Inc.
Sold states
Distributed in MA.
Affected count
25
Manufactured in
375 River Park Cir, N/A, Marquette, MI, United States
Products
Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2053-2015Don't want to check this manually?
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