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U.S. Department of Health and Human Services

Class 2 Device Recall PROSTIM 10cc INJECTABLE

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  Class 2 Device Recall PROSTIM 10cc INJECTABLE see related information
Date Initiated by Firm November 08, 2016
Create Date November 25, 2019
Recall Status1 Completed
Recall Number Z-0564-2020
Recall Event ID 84180
510(K)Number K083270  
Product Classification Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
Product PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
Code Information Lot Number 1564697
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 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

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.
510(K) Database 510(K)s with Product Code = MBP and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.