Thread-like wire marker
Reported: March 17, 2021 Initiated: February 3, 2021 #Z-1200-2021
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.
Details
- Recalling Firm
- Somatex Medical Technologies GMBH
- Units Affected
- 196 pieces
- Distribution
- Domestic: Mo, NJ, OH
- Location
- Berlin
Frequently Asked Questions
What product was recalled? ▼
Thread-like wire marker. Recalled by Somatex Medical Technologies GMBH. Units affected: 196 pieces.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 17, 2021. Severity: Moderate. Recall number: Z-1200-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11