CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report

Concorde Lift Driver Shaft AO recalled by DePuy Orthopaedics

DePuy Orthopaedics is recalling Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems, distributed nationwide in the US. The recall was initiated on 26 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct code: 287804101G Lot number: 052316-A R, 121416-A R

Quantity recalled130 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0848-2018
FDA event ID: 79072
Recalling firm: DePuy Orthopaedics, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 26 Jul 2017
FDA classified: 2 Mar 2018
Reported: 14 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

26 Jul 2017	Recall initiated by company
2 Mar 2018	Classified by FDA	+219 days
14 Mar 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for Intra-operative breakage of driver tips

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Potential for Intra-operative breakage of driver tips

Which lots are affected?

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

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 79072

This product is part of a recall event; the main page for the event is Concorde Lift Torque Limiting Handle recalled by DePuy Orthopaedics.

Reported	Class	Recall	Company	Reason	Where
14 Mar 2018	CLASS II	Concorde Lift Torque Limiting Handle recalled by DePuy Orthopaedics	DePuy Orthopaedics	Device Malfunction	Nationwide

More recalls from DePuy Orthopaedics

All 153

Reported	Class	Recall	Company	Reason	Where
10 Apr 2024Device	CLASS II	Attune Affixium Cementless Fixed Bearing Knee recalled	DePuy Orthopaedics	Labeling Errors	Nationwide
29 Mar 2023Device	CLASS II	Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert SM recalled	DePuy Orthopaedics	Other	Nationwide

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide