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.
Reported: December 30, 2020 Initiated: November 12, 2020 #Z-0638-2021
Product 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 for Recall
The product is mislabeled.
Details
- Recalling Firm
- Biocomposites, Ltd.
- Units Affected
- 54 boxes
- Distribution
- Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.
- Location
- Keele Staffordshire, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biocomposites, Ltd.. Units affected: 54 boxes.
Why was this product recalled? ▼
The product is mislabeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0638-2021.
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