Z-2765-2016Class II

SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer...

Name: Z-2765-2016 SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer...
Creator: Hologic, Inc
Published: 2016-08-02
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2016-08-02 / Terminated / root cause: manufacturing process

FDA source

Hologic, Inc began a recall of SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR... on 2016-08-02. FDA classified it as Class II and gives the reason as "Tip Breakage at the glue joint between the obturator body and tip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2765-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-02
Posted: 2016-09-08
Terminated: 2017-03-30
Recalling firm: Hologic, Inc.
Product: SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
Product code: GDF Guide, Needle, Surgical
Reason for recall: Tip Breakage at the glue joint between the obturator body and tip
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Hologic sent an Important Product Recall letter to customers in the United States through Certified letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory and cease use of all affected recalled product. Customers were asked to complete the enclosed Recall Response Card indicating whether you have any of the recalled product on hand, as well as the quantity of product that you have in stock.
Quantity in commerce: 1440 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot Codes: 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2765-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2765-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2766-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08

Product code GDF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)