| Date Initiated by Firm |
September 21, 2018 |
| Create Date |
April 11, 2019 |
| Recall Status1 |
Terminated 3 on April 22, 2020 |
| Recall Number |
Z-1129-2019 |
| Recall Event ID |
82353 |
| Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
| Product |
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433
Product Usage:
The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
|
| Code Information |
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 |
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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