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U.S. Department of Health and Human Services

Class 2 Device Recall Stimulan

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  Class 2 Device Recall Stimulan see related information
Date Initiated by Firm November 12, 2020
Create Date December 18, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-0638-2021
Recall Event ID 86755
510(K)Number K141830  
Product Classification Filler, bone void, calcium compound - Product Code MQV
Product Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.
Code Information Lot SK190610, Expiry June 2022
Recalling Firm/
Manufacturer		 Biocomposites, Ltd.
Keele Science Park
Keele Staffordshire United Kingdom
Manufacturer Reason
for Recall		 The product is mislabeled.
FDA Determined
Cause 2		 Labeling mix-ups
Action The recalling firm contacted the 2 impacted distributors (Puerto Rico and Costa Rica) at the time of awareness of the issue. Both distributors have identified affected product, quarantined affected product and product will be returned to the recalling firm.
Quantity in Commerce 54 boxes
Distribution Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = BIOCOMPOSITES LTD.
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