Needle, Tumor Localization
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
119 adverse event reports on file
- TULOCOct 9, 2024InjurySomatex Medical Technologies Gmbh1000408433-2024-00003
- TULOCJul 22, 2024InjurySomatex Medical Technologies Gmbh1000408433-2024-00001
- TULOCApr 14, 2023InjurySomatex Medical Technologies Gmbh1000408433-2023-00002
- MOLE REMOVER PENMar 31, 2022InjuryUnkMW5108715
- KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLEJan 27, 2022MalfunctionCook Inc1820334-2022-00128
- KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLEApr 27, 2021InjuryCook Inc1820334-2021-01236
- X-REIDY BREAST LESION LOCALIZATION NEEDLEFeb 15, 2021MalfunctionCook Inc1820334-2021-00335
- TUFLEXJan 29, 2021MalfunctionSomatex Medical Technologies Gmbh3016567401-2021-00001
- TUFLEXJan 26, 2021MalfunctionSomatex Medical Technologies Gmbh1000408433-2021-00001
- KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLEAug 27, 2020InjuryCook Inc1820334-2020-01577
Event type breakdown
Recalls
3 recall events for this product code
- Cook Inc.TerminatedFeb 29, 2016
Kopans Breast Lesion Localization Needle
Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids.
Z-1028-2016 · View FDA record ↗ - Alpha-Omega Services IncTerminatedJul 20, 2004
Template Needle, Series 17, 20 cm, with Threaded Female hub and Bent Stylet, Closed-End, Disposable.
Template needle may fracture leaving tip in patient.
Z-0570-04 · View FDA record ↗ - Somatex Medical Technologies GMBHTerminatedUnknown
Thread-like wire marker
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.
Z-1200-2021 · View FDA record ↗
Registered firms
24 firms currently registered for this product code
Shenzhen Xiazhifeng Electronic Co., Ltd
Shenzhen Guangdong, CN
Cook Incorporated
Bloomington, IN, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Ningbo Hysent Medical Technology Co., Ltd
Ningbo Zhejiang, CN
Remington Medical, Inc.
ALPHARETTA, GA, US
Cook Incorporated
Spencer, IN, US
Hive International Pvt Ltd.
Sialkot Punjab, PK
Allwin Medical Devices Pvt. Ltd.
Surat Gujarat, IN
Somatex Medical Technologies Gmbh
Blankenfelde-Mahlow Brandenburg, DE
Isomedix Operations Inc.
SPARTANBURG, SC, US
Teleflex Medical Llc
Morrisville, NC, US
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
H.s. Hospital Service S.p.a.
Rome Roma, IT
Somatex Medical Technologies Gmbh
Berlin, DE
Izi Medical Products Llc
Owings Mills, MD, US
Steris Corporation De Republica Dominicana, S.r.l.
Santo Domingo, DO
Medax S.r.l. Unipersonale
San Possidonio Modena, IT
Dfc Medical Llc
Houston, TX, US
Promotec-medizintechnik Gmbh
Blankenfelde / Mahlow Brandenburg, DE
Micro-tech (nanjing) Co., Ltd.
Nanjing Jiangsu, CN
Inka Surgical Instruments
Jandakot Western Australia, AU
Medicoplast International Gmbh
ILLINGEN Saarland, DE
Remington Medical, S.a.
Santo Domingo Este, DO
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.