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Terminated

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.

FDA Recall Z-0362-2007 · Posted 2007-01-23

Recalling FirmSuros Surgical Systems Inc.
Recall StatusTerminated
Product CodeKNW
Date Initiated2006-12-15
Date Terminated2007-05-04
Product Quantity1249 handpieces

Reason for Recall

The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.

Firm Action

Consignees were notified by phone beginning on 12/15/06 and by follow-up letter dated 12/19/06.

Root Cause

Other

Distribution Pattern

Nationwide.

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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