Keele Staffordshire, N/A, United Kingdom
Biocomposites, Ltd. recalls
1 recall recorded since 2018, most recently on 12 November 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 12 November 2020
- Terminated
- 27 April 2021
- Reason
- The product is mislabeled.
- Distribution
- Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0638-2021
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.