Z-0848-2018Class II

Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared...

Name: Z-0848-2018 Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared...
Creator: DePuy Orthopaedics, Inc.
Published: 2017-07-26
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2017-07-26 / Terminated

FDA source

DePuy Orthopaedics, Inc. began a recall of Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine on 2017-07-26. FDA classified it as Class II and gives the reason as "Potential for Intra-operative breakage of driver tips". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0848-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-26
Posted: 2018-03-02
Terminated: 2019-04-03
Recalling firm: Depuy Orthopaedics Inc.
Product: Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Potential for Intra-operative breakage of driver tips
FDA root cause: Under Investigation by firm
Action: On August 1, 2017, an Urgent Product Recall notice titled "CONCORDE LIFT DRIVER Driver Shaft and Torque Handle" was mailed to customers that received the affected instruments. The letter described the issue, potential hazard, and actions to be taken. The notice instructs customers to cease further distribution or use and to contact a DePuy Synthes Spine sales consultant to return the products subject to recall. Customers are to review, complete, sign, and return the business reply form provided to the firm within 5 business days of receipt of the notification. A copy of the notice should be forwarded to all staff that need to be informed, as well as, any facility that the affected device was further distributed to. Customers should direct any questions regarding this recall to their DePuy Synthes Spine Sales Consultant or the Clarke Madigan, DePuy Synthes Spine Recall Coordinator, at 508-828-609 or [email protected].
Quantity in commerce: 130 units total
Distribution: Nationwide Distribution
Product codes and lots: Product code: 287804101G Lot number: 052316-A R, 121416-A R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0848-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0848-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02
Z-0849-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02

Product code MAX

K171425Class IIConcorde LiftMedos International SARL / cleared 2017-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)