CORAIL HIGH OFFSET STEM Collarless SIZE 14

FDA Device Recall #Z-0594-2018 — Class II — July 12, 2017

Recall Summary

Recall Number Z-0594-2018
Classification Class II — Moderate risk
Date Initiated July 12, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm DePuy Orthopaedics, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 19

Product Description

CORAIL HIGH OFFSET STEM Collarless SIZE 14

Reason for Recall

Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).

Distribution Pattern

Nationally; US Consignees for this recall are the affected are US Distributors and US Medical Facilities (Hospitals/User Facilities) that may have purchased, used, or received the affected device.

Lot / Code Information

Part No. L20314 and Lot No. 5292130

Other Recalls from DePuy Orthopaedics, Inc.

Recall # Classification Product Date
Z-1456-2024 Class II ATTUNE AFFIXIUM Cementless Fixed Bearing Knee w... Mar 12, 2024
Z-1264-2023 Class II Attune Revision Limb Preservation System (LPS) ... Feb 15, 2023
Z-1267-2023 Class II Attune Posterior (PS) Fixed Bearing (FB) Tibial... Feb 15, 2023
Z-1263-2023 Class II Attune Revision Limb Preservation System (LPS) ... Feb 15, 2023
Z-1266-2023 Class II Attune Revision Limb Preservation System (LPS) ... Feb 15, 2023

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.