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

FDA Device Recall #Z-1323-2022 — Class II — May 20, 2022

Recall Summary

Recall Number Z-1323-2022
Classification Class II — Moderate risk
Date Initiated May 20, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm DePuy Spine, Inc.
Location Raynham, MA
Product Type Devices
Quantity 61 units

Product Description

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

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

Distribution Pattern

Distribution US Nationwide

Lot / Code Information

UDI-DI: 04260557770658 Lot Number: E20CL0603

Other Recalls from DePuy Spine, Inc.

Recall # Classification Product Date
Z-1324-2022 Class II EIT CIF cage, H 7mm, 8degree, S- an interverteb... May 20, 2022
Z-1225-2019 Class II Concorde Lift, Expandable Interbody Device, spi... Apr 8, 2019
Z-1226-2019 Class II Concorde Lift, Lordotic Expandable Interbody De... Apr 8, 2019
Z-1300-2018 Class II Confidence Plus Kit Spinal Cement System, Produ... Dec 15, 2017
Z-0627-2017 Class II DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SY... Oct 12, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.