Teltow, N/A, Germany
Somatex Medical Technologies GmbH recalls
2 recalls recorded since 2018, most recently on 3 February 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 3 February 2021
- Terminated
- 13 January 2022
- 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.
- Distribution
- Domestic: Mo, NJ, OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1200-2021
Terminated Class II Medical devices
- Recall started
- 22 May 2017
- Terminated
- 30 August 2018
- Reason
- There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.
- Distribution
- NY - Only one US distributor
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0410-2018
- TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.