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
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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
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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 |
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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 = MQV
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