| Class 2 Device Recall INBONE STEM, TIBIAL, TOP | |
Date Initiated by Firm | November 08, 2016 |
Create Date | November 25, 2019 |
Recall Status1 |
Terminated 3 on November 03, 2020 |
Recall Number | Z-0565-2020 |
Recall Event ID |
84180 |
510(K)Number | K051023 |
Product Classification |
Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
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Product | INBONE STEM, TIBIAL, TOP, Part Number 200011901 |
Code Information |
Lot Number 1540433 |
Recalling Firm/ Manufacturer |
Wright Medical Technology, Inc. 11576 Memphis Arlington Rd Arlington TN 38002-9497
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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 | 65 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 |
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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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510(K) Database | 510(K)s with Product Code = HSN
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