FDA-Device2013-05-15Class III

Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Spinal Elements, Inc
Hazard

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Sold states
Distributed in OH and PA.
Affected count
68 units total
Manufactured in
3115 Melrose Dr, Suite 200, Carlsbad, CA, United States
Products
Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1261-2013

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