Z-0638-2021 Class II Terminated
FDA device recall Z-0638-2021 was initiated by Biocomposites, Ltd. on November 12, 2020 and is designated Class II. Reason for recall: The product is mislabeled. The recall status is terminated (terminated April 27, 2021). Affected quantity: 54 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 12, 2020
- Termination Date
- April 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54 boxes
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.
Distribution Pattern
Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.
Code Information
Lot SK190610, Expiry June 2022