Recall Z-0362-2007 ยท KNW Instrument, Biopsy
Suros Surgical Systems Inc.
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.
| Date | Jan 23, 2007 (initiated Dec 15, 2006) |
| Status | Terminated |
| Reason | The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle. |
| Root cause | Other |
| Action | Consignees were notified by phone beginning on 12/15/06 and by follow-up letter dated 12/19/06. |
| Quantity | 1249 handpieces |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |