SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Se
FDA device recall Z-2765-2016 · posted 2016-09-08 · Terminated
Recall details
- Recalling firm
- Hologic, Inc
- Reason for recall
- Tip Breakage at the glue joint between the obturator body and tip
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GDF
- Quantity affected
- 1440 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2016-08-02
- Date posted
- 2016-09-08
- Date terminated
- 2017-03-30
- Location
- Marlborough, MA
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