—#171430

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On September 21, 2018, the firm notified customers via email that rework was required for the affected product. Customers were advised that the three affected product codes were produced with an O-Ring until a 2010 design change removed the O-Ring as a rolling change. Customers were provided with work instructions for how to rework the product by removing the O-Ring. Please Take the Following Urgent Actions: 1. Please continue to follow the instructions for use in IFU-W90946 Rev B regarding cleaning of these devices. 2. Immediately review your inventory and rework the affected units. Your DePuy Synthes Sales Consultant can assist with the rework. o Reconciliation Form: Complete the reconciliation form and return to your sales consultant or fax to 574-371-4939 or email to klong16@its.jnj.com within five (5) days of this notice. o Records: Retain a copy of the completed reconciliation form in your files along with this notice. 3. Additional Notifications: o Notify surgeons at your facility by providing them with a copy of this notice. Forward this notice to others in your facility that need to be informed. For product-related questions, please contact your local DePuy Orthopaedics, Inc. Sales Consultant. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific and Medical Affairs mailbox RA-DPYUS-DePSynSc@ITS.JNJ.com. For questions about the information provided, please contact Kim Earle, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. 5 p.m. EDT).

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

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.

Timeline

Recall initiated: 2018-09-21
Terminated: 2020-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171430. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.