CLASS II Device recall · Reported 8 May 2019 · FDA Enforcement Report

Concorde Lift, Lordotic Expandable Interbody Device recalled

DePuy Spine is recalling Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant, distributed nationwide in the US. The recall was initiated on 8 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled3166 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-1226-2019
FDA event ID: 82587
Recalling firm: DePuy Spine, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 8 Apr 2019
FDA classified: 26 Apr 2019
Reported: 8 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

8 Apr 2019	Recall initiated by company
26 Apr 2019	Classified by FDA	+18 days
8 May 2019	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

A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.

Product as listed by the FDA

Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)

Where it was distributed

US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.

Which lots are affected?

All lots

Where was it sold?

US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.

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 82587

This product is part of a recall event; the main page for the event is Concorde Lift, Expandable Interbody Device recalled by DePuy Spine.

Reported	Class	Recall	Company	Reason	Where
8 May 2019	CLASS II	Concorde Lift, Expandable Interbody Device recalled by DePuy Spine	DePuy Spine	Other	Nationwide

More recalls from DePuy Spine

All 36

Reported	Class	Recall	Company	Reason	Where
13 Jul 2022Device	CLASS II	EIT CIF cage, H, 8degree, L- an intervertebral body fusion recalled	DePuy Spine	Packaging Defects	Nationwide
13 Jul 2022Device	CLASS II	EIT CIF cage, H, 8degree, S- an intervertebral body fusion recalled	DePuy Spine	Packaging Defects	Nationwide
8 May 2019Device	CLASS II	Concorde Lift, Expandable Interbody Device recalled by DePuy Spine	DePuy Spine	Other	Nationwide
11 Apr 2018Device	CLASS II	Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 recalled	DePuy Spine	Other	MA
30 Nov 2016Device	CLASS II	Skyline Anterior Cervical Plate System Variable recalled by DePuy Spine	DePuy Spine	Packaging Defects	15 states

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