Biocomposites, Ltd.: Medical Device Recall in 2020 - (Recall #: Z-0638-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 12, 2020

Date Posted: December 30, 2020

Recall Number: Z-0638-2021

Event ID: 86755

Reason for Recall:

The product is mislabeled.

Status: Terminated

Product Quantity: 54 boxes

Code Information:

Lot SK190610, Expiry June 2022

Distribution Pattern:

Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.

Voluntary or Mandated:

Voluntary: Firm initiated