FDA-Device2018-03-14Class II
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
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 Torque Limiting Handle. Must be 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-0849-2018Don't want to check this manually?
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