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CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAI...

FDA Device Recall #Z-1129-2019 — Class II — September 21, 2018

Recall Summary

Recall Number Z-1129-2019
Classification Class II — Moderate risk
Date Initiated September 21, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm DePuy Orthopaedics, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 12639 total

Product Description

CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

Reason for Recall

There is the potential for debris/material to be found behind the O-rings in the neck trials.

Distribution Pattern

Worldwide Distribution - US Nationwide Distributed to accounts in AL AZ CA CO FL GA HI IA IL IN KY LA MA MD ME MI MN MS NC ND NH NJ NV NY OH OR PA SC TN TX UT VA WA, and WI. International distribution worldwide.

Lot / Code Information

1216681 1216682 1230767 1230768 1230769 1700574 1700577 1781383 1812717 1817782 1860266 1865894 1874691 1874694 1874697 1885308 1899216 1899217 1910189 2002012 2024021 2043430 2043430 2065508 2065508 2078241 2078241 2102703 2102703 2102704 2102704 2129113 2129113 2142423 2142423 2153325 2153325 2153326 2153326 2173203 2173203 2249175 2249176 2249177 2252365 2274507 2284309 2284310 2309652 2309653 2309654 2336394 2336395 2362088 2362089 2380244 2384477 2384478 2401667 2416621 2416622 2424599 2465283 2465284 2465285 2465289 2487632 2490517 2490518 2513467 2515079 2526367 2526368 2565627 2565714 2565715 2572844 2572845 2572846 2609035 2609037 2617683 2617684 2643413 2643414 2673438 2673439 2673440 2691548 2691549 2749290 2761213 2795714 2795715 2795716 2811225 2811226 2811231 2811232 2823044 2836720 2836721 2836722 5002110 5002111 5002112 5002113 5005841 5005842 5008236 5008237 5009207 5012217 5012218 5016197 5016198 5017028 5017030 5019843 1812717A 1812717A

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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.

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