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Terminated

ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100 Technology Center DR. Indianapolis, IN 46278. The handpiece is inserted into the breast to the site of the area of interest. When the proper location/[position is achieved, the handpiece cuts and removes biopsy tissue.

FDA Recall Z-1160-2010 · Posted 2010-03-18

Recalling FirmHologic, Inc.
Recall StatusTerminated
Product CodeKNW
Date Initiated2010-02-01
Date Terminated2010-10-08
Product Quantity190

Reason for Recall

The product is labeled as ATEC0909-12 but it actually contains 0909-20.

Firm Action

Formal recall notification letters and response forms were sent to customers via FEDEX on February 1, 2010. If there are any questions, please call 317.344.7630.

Root Cause

Employee error

Distribution Pattern

US and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042290VACUUM ASSISTED CORE BIOPSY DEVICESuros Surgical Systems, Inc. · 2004-10-06K010400VACUUM ASSISTED CORE BIOPSY DEVICEPromex, Inc. · 2001-07-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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