Recall Z-0638-2021 ยท MQV Filler, Bone Void, Calcium Compound
Biocomposites, Ltd.
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.
| Date | Nov 12, 2020 |
| Status | Terminated |
| Reason | The product is mislabeled. |
| Root cause | 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 | 54 boxes |
| Distribution | Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141830 | STIMULAN KIT, STIMULAN RAPID CURE Biocomposites, Ltd., Jan 23, 2015 |