FDA Medical Device Recalls (openFDA)
DePuy Spine, Inc.: 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
- Recall number
- Z-1324-2022
- Recalling firm
- DePuy Spine, Inc.
- Product
- 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
- Status
- Open, Classified
- Initiated
- 2022-05-20
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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 OneMD-Field-Actions@its.jnj.com 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
- 46 units
- Distribution
- Distribution US Nationwide
- Lot, serial or model codes
- UDI-DI: 04260557770573 Lot Number: E20CL0637
- 510(k) numbers
- ["K170503"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 1526439
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28