Recall Z-0638-2021
Biocomposites, Ltd. · initiated November 12, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot SK190610, Expiry June 2022
Reason for recall
The product is mislabeled.
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-0638-2021
- Initiated
- November 12, 2020
- Terminated
- April 27, 2021
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Quantity
- 54 boxes
- Distribution
- Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.
- Recalling firm
- Biocomposites, Ltd., Keele Staffordshire