FDA recall Z-0849-2018

DePuy Orthopaedics, Inc. · Class II · device

Product

Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

Reason for recall

Potential for Intra-operative breakage of driver tips

Distribution

Nationwide Distribution

Key facts

Status: Terminated
Initiation date: 2017-07-26
Report date: 2018-03-14
Termination date: 2019-04-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0849-2018