CLASS II Device recall · Reported 17 Apr 2019 · FDA Enforcement Report

Corail Amt Coxa Vara Neck Segment (Kla) Pro recalled

DePuy Orthopaedics is recalling Corail Amt Coxa Vara Neck Segment (Kla) Pro, distributed nationwide in the US. The recall was initiated on 21 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1212912 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

Quantity recalled12639 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1128-2019
FDA event ID: 82353
Recalling firm: DePuy Orthopaedics, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 21 Sep 2018
FDA classified: 11 Apr 2019
Reported: 17 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

21 Sep 2018	Recall initiated by company
11 Apr 2019	Classified by FDA	+202 days
17 Apr 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arizona California Colorado Florida Georgia Iowa Illinois Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Mississippi North Carolina North Dakota New Hampshire New Jersey Nevada

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 82353

This product is part of a recall event; the main page for the event is Corail Amt Standard Offset Neck Segment (Std), Pro recalled.

Reported	Class	Recall	Company	Reason	Where
17 Apr 2019	CLASS II	Corail Amt Standard Offset Neck Segment (Std), Pro recalled	DePuy Orthopaedics	Other	Nationwide
17 Apr 2019	CLASS II	Corail Amt High Offset Neck Segment (Kho), Pro recalled	DePuy Orthopaedics	Other	Nationwide

More recalls from DePuy Orthopaedics

All 153

Reported	Class	Recall	Company	Reason	Where
10 Apr 2024Device	CLASS II	Attune Affixium Cementless Fixed Bearing Knee recalled	DePuy Orthopaedics	Labeling Errors	Nationwide
29 Mar 2023Device	CLASS II	Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert SM recalled	DePuy Orthopaedics	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide