Z-0849-2018 Class II Terminated

Recalled by DePuy Orthopaedics, Inc. — Raynham, MA

Recall Details

Product Type
Devices
Report Date
March 14, 2018
Initiation Date
July 26, 2017
Termination Date
April 3, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
130 units total

Product Description

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 Pattern

Nationwide Distribution

Code Information

Product code: 287804102 Lot number: 122315-B R, 122315-A R, 041117A