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U.S. Department of Health and Human Services

Class 2 Device Recall SureSight Obturator Introducer Localization Systems

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 Class 2 Device Recall SureSight Obturator Introducer Localization Systemssee related information
Date Initiated by FirmAugust 02, 2016
Date PostedSeptember 08, 2016
Recall Status1 Terminated 3 on March 30, 2017
Recall NumberZ-2765-2016
Recall Event ID 74839
Product Classification Guide, needle, surgical - Product Code GDF
ProductSureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
Code Information Lot Codes: 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547. 
FEI Number 1000120743
Recalling Firm/
Manufacturer		 Hologic, Inc
250 Campus Dr
Marlborough MA 01752-3020
For Additional Information ContactSAME
508-263-8920
Manufacturer Reason
for Recall		Tip Breakage at the glue joint between the obturator body and tip
FDA Determined
Cause 2		Process control
ActionHologic 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 Commerce1440 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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