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EIT CIF cage recallZ-1324-2022 · DePuy Spine, Inc. · initiated May 20, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DePuy Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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

FDA root cause category: Labeling Change Control

What the company is doing

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

Recall details

Recall number
Z-1324-2022
Status
Open, Classified
Initiated by the company
May 20, 2022
Recalling firm
DePuy Spine, Inc.
Quantity
46 units
Product code
MAX
FDA submissions
K170503
Distribution
Distribution US Nationwide

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 04260557770573 Lot Number: E20CL0637

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

41 devices cleared under K170503 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 90390).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page