| Date Initiated by Firm |
September 21, 2018 |
| Create Date |
April 11, 2019 |
| Recall Status1 |
Terminated 3 on April 22, 2020 |
| Recall Number |
Z-1128-2019 |
| Recall Event ID |
82353 |
| Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
| 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.
|
| Code Information |
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 |
Recalling Firm/
Manufacturer |
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
|
| For Additional Information Contact |
Complaints Team
866-811-9367
|
Manufacturer Reason
for Recall |
There is the potential for debris/material to be found behind the O-rings in the neck trials.
|
FDA Determined
Cause 2 |
Nonconforming Material/Component |
| Action |
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). |
| Quantity in Commerce |
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. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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