Recall Z-1200-2021— Somatex Medical Technologies GMBH
Class II · Terminated
Class II FDA medical device recall by Somatex Medical Technologies GMBH, initiated 2021-02-03, terminated 2022-01-13. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Somatex Medical Technologies GMBH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-03
- Terminated
- 2022-01-13
- Firm location
- Berlin, Germany
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.