🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: September 21, 2018 DePuy Orthopaedics Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
DePuy Orthopaedics, Inc.
Reason for Recall:
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1127-2019

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