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U.S. Department of Health and Human Services

Class 2 Device Recall INBONE Tibial Tray

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  Class 2 Device Recall INBONE Tibial Tray see related information
Date Initiated by Firm April 09, 2020
Create Date May 07, 2020
Recall Status1 Open3, Classified
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HSN and Original Applicant = TOPEZ ORTHOPEDICS, INC
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