CLASS II ONGOING Device recall · Reported 13 Jul 2022 · FDA Enforcement Report

EIT CIF cage, H, 8degree, L- an intervertebral body fusion recalled

DePuy Spine is recalling EIT CIF cage, H, 8degree, L- an intervertebral body fusion devices indicated for use with, distributed nationwide in the US. The recall was initiated on 20 May 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 04260557770658 Lot Number: E20CL0603

Quantity recalled61 units

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-1323-2022
FDA event ID: 90390
Recalling firm: DePuy Spine, Raynham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 20 May 2022
FDA classified: 1 Jul 2022
Reported: 13 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Spinal Implants

Timeline

20 May 2022	Recall initiated by company
1 Jul 2022	Classified by FDA	+42 days
13 Jul 2022	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

Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI8060L

Where it was distributed

Distribution US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton

Which lots are affected?

UDI-DI: 04260557770658 Lot Number: E20CL0603

Where was it sold?

Distribution US Nationwide

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 90390

This product is part of a recall event; the main page for the event is EIT CIF cage, H, 8degree, S- an intervertebral body fusion recalled.

Reported	Class	Recall	Company	Reason	Where
13 Jul 2022	CLASS II	EIT CIF cage, H, 8degree, S- an intervertebral body fusion recalled	DePuy Spine	Packaging Defects	Nationwide

More recalls from DePuy Spine

All 36

Reported	Class	Recall	Company	Reason	Where
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, Lordotic Expandable Interbody Device recalled	DePuy Spine	Other	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 1,161

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: Spinal CDS recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Anterior Spine Pack recalled	Medline Industries	Other	Nationwide
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide