FDA Recall
Terminated
Thread-like wire marker
Recall: Z-1200-2021
·
Initiated February 3, 2021
Recall
- Recall Number
- Z-1200-2021
- Event Number
- 87317
- Firm
- Somatex Medical Technologies GMBH Hohenzollerndamm 150-151 Berlin Germany
- FEI Number
- 1000408433
- Product Code
- MIJ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- February 3, 2021
- Terminated
- January 13, 2022
Description
Thread-like wire marker
Reason
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.
Action
On 1/22/2021, Somatex issued an Urgent Medical Device Removal notice to customers via e-mail for Tuflex and Tuflex Premium marking wires. This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion.
Distribution
Domestic: Mo, NJ, OH
Quantity
196 pieces