Recall Z-0848-2018— DePuy Orthopaedics, Inc.

Name: FDA recall Z-0848-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-26

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2017-07-26, terminated 2019-04-03. It names one FDA 510(k) clearance: K171425. Product: Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.. Reason: Potential for Intra-operative breakage of driver tips.

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-26
Terminated: 2019-04-03
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K171425 — CONCORDE LIFTMedos International SARL·cleared 2017-07-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.