FDA recall Z-0848-2018

Product

Concorde Lift Driver Shaft AO. 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-0848-2018