FDAClass IIApril 17, 2019

Corail AMT High Offset Neck Segment recall

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

Why was Corail AMT High Offset Neck Segment recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL…
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
12639 total
Distribution
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.
Recall date
April 17, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls