Recall Z-0638-2021— Biocomposites, Ltd.

Name: FDA recall Z-0638-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-12

Class II · Terminated

Class II FDA medical device recall by Biocomposites, Ltd., initiated 2020-11-12, terminated 2021-04-27. It names one FDA 510(k) clearance: K141830. 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.. Reason: The product is mislabeled..

Recalling firm: Biocomposites, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2020-11-12
Terminated: 2021-04-27
Firm location: Keele Staffordshire, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K141830 — STIMULAN KIT, STIMULAN RAPID CUREBiocomposites, Ltd.·cleared 2015-01-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.