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  Class 2 Device Recall EVANS OPENING WEDGE PLATE 10MM see related information
Date Initiated by Firm November 08, 2016
Create Date November 25, 2019
Recall Status1 Completed
Recall Number Z-0569-2020
Recall Event ID 84180
Product Classification Plate, fixation, bone - Product Code HRS
Product EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
Code Information Lot Number 1556150
Recalling Firm/
Wright Medical Technology, Inc.
11576 Memphis Arlington Rd
Arlington TN 38002-9497
Manufacturer Reason
for Recall
The firm discovered a lack of adequate documentation confirming sterility on certain products.
FDA Determined
Cause 2
Process control
Action The firm initiated the recall on 11/08/2016 by letter and email to the user level. The firm requested the return of the units.
Quantity in Commerce 30 units
Distribution US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
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.