Z-1323-2022Class II

EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when...

Name: Z-1323-2022 EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when...
Creator: DePuy Spine, Inc.
Published: 2022-05-20
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2022-05-20 / Open, Classified / root cause: labeling and UDI

FDA source

DePuy Spine, Inc. began a recall of 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... on 2022-05-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1323-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-20
Posted: 2022-07-01
Recalling firm: DePuy Spine, Inc.
Product: 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
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: DePuy Synthes Spine issued Urgent Medical Device Recall Letter dated 5/18/21 to hospitals, sales consultants and sales managers. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the subject products and quarantine the subject products. DO NOT USE THE SUBJECT PRODUCTS. 2. Contact your DePuy Synthes Spine Sales Consultant to coordinate the return/credits of the subject products. 3. Review, complete, sign, and return the attached Business Response Form (See page 3 of this communication) to [email protected] within three (3) business days of receipt of this notification. Please include FA 2113300: 2022 EIT Cage in the e-mail subject line. IMPORTANT: Please complete the attached Business Response Form even if you do not have any units of the subject product on hand. 4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). 5. If any of the subject product has been forwarded to another facility, contact that facility, and provide them with a copy of this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your record. Contact your DePuy Synthes Spine Sales Consultant. For Medical Information Requests, please visit our website: https://www.jnjmedicaldevices.com/mir
Quantity in commerce: 61 units
Distribution: Distribution US Nationwide
Product codes and lots: UDI-DI: 04260557770658 Lot Number: E20CL0603

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1323-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1323-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-01
Z-1324-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-01

Product code MAX

K170503Class IIEIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF CagesEit Emerging Implant Technologies GmbH / cleared 2017-07-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)