FDAClass IIMarch 14, 2018

Concorde Lift Driver Shaft AO. Used with supplemental recall

Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

Why was Concorde Lift Driver Shaft AO. Used with supplemental recalled?

Potential for Intra-operative breakage of driver tips

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product code: 287804101G Lot number: 052316-A R, 121416-A R

Product
Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
130 units total
Distribution
Nationwide Distribution
Recall date
March 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls