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Class 2 Device Recall PROSTIM 10cc INJECTABLE |
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Date Initiated by Firm |
November 08, 2016 |
Create Date |
November 25, 2019 |
Recall Status1 |
Terminated 3 on November 03, 2020 |
Recall Number |
Z-0564-2020 |
Recall Event ID |
84180 |
510(K)Number |
K083270
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Product Classification |
Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
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Product |
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410 |
Code Information |
Lot Number 1564697 |
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.
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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 |
19 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 = MBP and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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