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Suros ATEC Breast Biopsy System handpiece (9 gauge cannula… recallZ-0362-2007 · Suros Surgical Systems Inc. · initiated Dec 15, 2006

Terminated All recalls posted in January 2007

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Suros Surgical Systems Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Other

What the company is doing

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

Recall details

Recall number
Z-0362-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 15, 2006
Posted by the FDA
Jan 23, 2007
Recalling firm
Suros Surgical Systems Inc.
Quantity
1249 handpieces
Product code
KNW
FDA submissions
K010400, K042290
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.

Code information (models, lots, serial numbers)

Lot 611018.

Other devices under the same FDA submission

15 devices cleared under K010400, K042290 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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