Recall Z-0275-2009
Hologic, Inc. · initiated September 22, 2008
Product
ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc., Indianapolis, IN; Model number ATEC 1212-20. Intended for partial or complete removal of tissue samples for diagnostic testing.
Codes / lots: Lots 804038, 804050, 804067, 804085, 805049, 805054, 805064, 805080, 806004, 806016, 806051, 806066 and 806121.
Reason for recall
The distal tip of the needle may become detached and remain in the patient, requiring surgical removal.
FDA-determined cause: Process control
Action taken
Consignees were notified via an Urgent Medical Device Recall letter dated 9/17/08 asking them to immediately check their inventories and quarantine all affected product from the listed lots. Also, if the product had been further distributed, users were to be identified and notified of the recall. Products are to be held in quarantine until they are returned to Hologic. The response form must be completed and returned to fulfill regulatory requirements and document actions taken at your facility. Handpieces whose pouches had been opened were to be destroyed, as they could potentially shift during transport and expose dangerous sharp points to personnel handling the boxes. Upon receipt of the attached response form, Hologic will promptly send an equivalent amount of replacement product free of charge.
Details
- Recall number
- Z-0275-2009
- Initiated
- September 22, 2008
- Posted by FDA
- November 7, 2008
- Terminated
- November 18, 2009
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 5,120 (1,024 cases of 5)
- Distribution
- Worldwide Distribution --- including USA and countries of Australia, Belgium, Brazil and Singapore.
- Recalling firm
- Hologic, Inc., Indianapolis, IN