Date Initiated by Firm |
April 09, 2020 |
Create Date |
May 07, 2020 |
Recall Status1 |
Terminated 3 on November 02, 2020 |
Recall Number |
Z-1924-2020 |
Recall Event ID |
85439 |
510(K)Number |
K051023
|
Product Classification |
Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
|
Product |
WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. |
Code Information |
Lot code 1619947 |
Recalling Firm/ Manufacturer |
Wright Medical Technology Inc 11576 Memphis Arlington Rd Arlington TN 38002-9497
|
For Additional Information Contact |
Mr. Kevin C. Smith 952-921-7121
|
Manufacturer Reason for Recall |
One lot of INBONE Tibial Trays is missing the plasma coating.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm initiated the recall by letter on 04/09/2020. The letter requested the consignee immediately cease use and quarantine the product for return. |
Quantity in Commerce |
22 units |
Distribution |
US Nationwide distribution. |
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.
|
510(K) Database |
510(K)s with Product Code = HSN and Original Applicant = TOPEZ ORTHOPEDICS, INC
|