Devices

Device Recall Kopans Breast Lesion Localization Needle

Model / Serial
Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..
Product Description
Kopans Breast Lesion Localization Needle || The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during needle manipulation. The Kopans Breast Lesion Localization Needle is intended for preoperative marking of nonpalpable breast lesions.
Manufacturer
Cook Inc.
1 Event
- Recall of Device Recall Kopans Breast Lesion Localization Needle

Manufacturer

Cook Inc.

Manufacturer Address
Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
Manufacturer Parent Company (2017)
Cook Group Incorporated
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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