FDA recall Z-0638-2021

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 for recall

The product is mislabeled.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-11-12

Report date

2020-12-30

Termination date

2021-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Keele Staffordshire, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0638-2021