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CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected C...

FDA Device Recall #Z-1127-2019 — Class II — September 21, 2018

Recall Summary

Recall Number Z-1127-2019
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 STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 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

lots 1212901 1218481 1226220 1230761 1230762 1700575 1781381 1812714 1817780 1860264 1865892 1874689 1874692 1874695 1885306 1899212 1899213 1910187 1979239 2002010 2024019 2043428 2043428 2078239 2078239 2102693 2102693 2129111 2129111 2153317 2153317 2153318 2153318 2153319 2153319 2153320 2153320 2163174 2163174 2249115 2249116 2252364 2274452 2275487 2284306 2284307 2309644 2309645 2309646 2336389 2336390 2362086 2362087 2380243 2384473 2384474 2386339 2401664 2401665 2416615 2416617 2416618 2465273 2465274 2465275 2465287 2490513 2490514 2513465 2513466 2526363 2526364 2539884 2539885 2565583 2572825 2572826 2602513 2602514 2605764 2605765 2643408 2643409 2648066 2648067 2673433 2673434 2691497 2691501 2739089 2739090 2749282 2749283 2774407 2774408 2774409 2774410 2795717 2795718 2795719 2811227 2811228 2811233 2811234 2836707 2836708 2836709 5001519 5001520 5001521 5001522 5005846 5005847 5008238 5008239 5009208 5016192 5016193 5016194 5016195 5016196 5019838 5019841 1812714A 1812714A

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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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