Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-1324-2022 · Posted None

Recalling FirmDePuy Spine, Inc.
Recall StatusOpen, Classified
Product CodeMAX
Date Initiated2022-05-20
Product Quantity46 units

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

Firm 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

Root Cause

Labeling Change Control

Distribution Pattern

Distribution US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑