DePuy Orthopaedics, Inc. recalls Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cl…

Recall date

July 26, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0849-2018

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

Potential for Intra-operative breakage of driver tips

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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