FDA Recall
Terminated
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.
Recall: Z-0638-2021
·
Initiated November 12, 2020
Recall
- Recall Number
- Z-0638-2021
- Event Number
- 86755
- Firm
- Biocomposites, Ltd. Keele Science Park Keele Staffordshire United Kingdom
- FEI Number
- 3002806534
- Product Code
- MQV
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- November 12, 2020
- Terminated
- April 27, 2021
Description
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.
Reason
The product is mislabeled.
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.
Distribution
Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.
Quantity
54 boxes