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Class 2 Device Recall Metzenbaum Scissors 7, Curved, Sterile |
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Date Initiated by Firm |
October 28, 2016 |
Date Posted |
December 13, 2016 |
Recall Status1 |
Terminated 3 on April 17, 2017 |
Recall Number |
Z-0752-2017 |
Recall Event ID |
75710 |
Product Classification |
Scissors, general, surgical - Product Code LRW
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Product |
Metzenbaum Scissors 7, Curved, Sterile
The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures. |
Code Information |
Catalog # ST5-182; lot# 355 |
Recalling Firm/ Manufacturer |
Integra York PA, Inc 589 Davies Dr York PA 17402-8630
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For Additional Information Contact |
Dr. Patricia W. Kihn 717-309-3966
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Manufacturer Reason for Recall |
The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
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FDA Determined Cause 2 |
Process control |
Action |
The firm, Integra, mailed an "URGENT MEDICAL DEVICE RECALL NOTICE" dated October 26, 2016 to customers affected by the recall to notify them of the issue. The notice described the product, problem and actions to be taken. The customers were instructed to immediately review their inventory to determine if they had any of the recalled product on hand and to discontinue distributing the product; review your customer traceability records for shipment of the product and forward a copy of this Recall Notice to any of your customers that purchased the affected lots; complete and return the Acknowledgement Form that accompanied the notice (even if you do not have any product(s)) by email to: FCA3@integralife.com or fax to: 1-609-750-4220.
Should you have any questions regarding these instructions, please contact Customer Service at 1-866-854-8300. |
Quantity in Commerce |
50 units |
Distribution |
US Distribution in NC and TX. |
Total Product Life Cycle |
TPLC Device Report
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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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