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.
FDA Recall Z-0638-2021 · Posted None
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Recalling FirmBiocomposites, Ltd.
Recall StatusTerminated
Product CodeMQV
Date Initiated2020-11-12
Date Terminated2021-04-27
Product Quantity54 boxes
Reason for Recall
The product is mislabeled.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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