CLASS II ONGOING Device recall · Reported 13 Jul 2022 · FDA Enforcement Report
EIT CIF cage, H, 8degree, S- an intervertebral body fusion recalled
DePuy Spine is recalling EIT CIF cage, H, 8degree, S- 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
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-1324-2022
- 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 7mm, 8degree, S- 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: CUI8070S
Where it was distributed
Distribution US Nationwide
Questions about this recall
Is EIT CIF cage, H, 8degree, S- an intervertebral body fusion devices indicated for use with recalled?
Yes. DePuy Spine recalled EIT CIF cage, H, 8degree, S- an intervertebral body fusion devices indicated for use with on 20 May 2022. The recall is Class II and its status is Ongoing. Recall number Z-1324-2022.
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: 04260557770573 Lot Number: E20CL0637
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from DePuy Spine
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EIT CIF cage, H, 8degree, L- an intervertebral body fusion recalled | DePuy Spine | Packaging Defects | Nationwide |
| Device | CLASS II | Concorde Lift, Lordotic Expandable Interbody Device recalled | DePuy Spine | Other | Nationwide |
| Device | CLASS II | Concorde Lift, Expandable Interbody Device recalled by DePuy Spine | DePuy Spine | Other | Nationwide |
| Device | CLASS II | Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 recalled | DePuy Spine | Other | Nationwide |
| Device | 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |