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Manufacturers
Suros Surgical Systems Inc.
Manufacturer Address
Suros Surgical Systems Inc., 6100 Technology Center Dr, Indianapolis IN 46278-6016
Source
USFDA
2 Events
Recall of Device Recall Suros ATEC Breast Biopsy System
Recall of Device Recall ATEC
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2 devices in the database
Device Recall Suros ATEC Breast Biopsy System
Model / Serial
Lot 611018.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20.
Device Recall ATEC
Model / Serial
Needle guide lot numbers 603006, exp. 3/1/2008, and 602013, exp. 2/6/2008.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.
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