FDA-Device2018-03-14Class II

Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

DePuy Orthopaedics, Inc.
Hazard

Potential for Intra-operative breakage of driver tips

Sold states
Nationwide Distribution
Affected count
130 units total
Manufactured in
325 Paramount Dr, N/A, Raynham, MA, United States
Products
Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0848-2018

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