FDA Device recall Z-1128-2019
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro
- FDA Device
- Class II
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class II recall of CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro by Depuy Orthopaedics, citing there is the potential for debris/material to be found behind the O-rings in the neck trials.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1128-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-21 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
Reason
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Identifiers
| code_info | 1212912 1216680 1230766 1700576 1812715 1812716 1817781 1860265 1865893 1874690 1874693 1874696 1885307 18…1212912 1216680 1230766 1700576 1812715 1812716 1817781 1860265 1865893 1874690 1874693 1874696 1885307 1899214 1899215 1910188 1979242 2002011 2024020 2043429 2043429 2078240 2078240 2102701 2102701 2129112 2129112 2153321 2153321 2153322 2153322 2153323 2153323 2153324 2153324 2173202 2173202 2284268 2284304 2284305 2309647 2309648 2309649 2336392 2336393 2384475 2384476 2386340 2401666 2416616 2416619 2416620 2465280 2465288 2481312 2490516 2511420 2526365 2565598 2565705 2565706 2572839 2572840 2605839 2605840 2609135 2609141 2643411 2643412 2673435 2673436 2673437 2691532 2691533 2739091 2739092 2749286 2774417 2774418 2774419 2795761 2795762 2795763 2811229 2811230 2811235 2811236 2836712 2836713 2836714 5002114 5002115 5002116 5005843 5005844 5005845 5012219 5012220 5016191 5017033 5017035 1812716A 1812716A |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1128-2019%22
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