FDA recall Z-1200-2021

Product

Thread-like wire marker

Reason for recall

This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body.

Distribution

Domestic: Mo, NJ, OH

Key facts

Status

Terminated

Initiation date

2021-02-03

Report date

2021-03-17

Termination date

2022-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berlin, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1200-2021