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.
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 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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