Date Initiated by Firm |
October 31, 2022 |
Date Posted |
November 21, 2022 |
Recall Status1 |
Completed |
Recall Number |
Z-0273-2023 |
Recall Event ID |
91039 |
510(K)Number |
K113060
|
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product |
Unity Total Knee System.
Used for knee prosthesis in total knee replacement |
Code Information |
Model Number: 112.040.06; Lot Number: 504337 |
Recalling Firm/ Manufacturer |
Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
|
For Additional Information Contact |
441285659866
|
Manufacturer Reason for Recall |
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Corin Group notified consignees on 10/31/2022 via letter titled "URGENT MEDICAL DEVICE RECALL." The letter instructed consignees to examine inventory, quarantine affected product, arrange for its return, and notify all facilities/personnel if devices were further distributed. Consignees were also asked to complete and return the acknowledgement form by e-mail to vigilance@coringroup.com.
For all questions on this notice, please contact me at +1 772-321-2478 or by e-mail to
vigilance@coringroup.com. |
Quantity in Commerce |
4 devices |
Distribution |
Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France. |
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.
|
510(K) Database |
510(K)s with Product Code = JWH and Original Applicant = CORIN U.S.A.
|