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Class 2 Device Recall InSpan Inserter |
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Date Initiated by Firm |
May 07, 2013 |
Date Posted |
July 05, 2013 |
Recall Status1 |
Terminated 3 on January 11, 2016 |
Recall Number |
Z-1666-2013 |
Recall Event ID |
65442 |
Product Classification |
Screwdriver - Product Code HXX
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Product |
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly
Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.
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Code Information |
Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R |
Recalling Firm/ Manufacturer |
SpineFrontier, Inc. 500 Cummings Ctr Ste 3500 Beverly MA 01915-6516
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For Additional Information Contact |
Helen Moon 978-232-3990
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Manufacturer Reason for Recall |
Potential for set screw to be come deformed.
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FDA Determined Cause 2 |
Device Design |
Action |
Spine Frontier sent an Urgent Advisory Notice letter dated May 30, 2013 to all affected consignees. The letter identified the affected product. problem and actions to be taken. The letter informed consignees that a correction was implemented for InSpan Inserters. Consignees were instructed to remove parts from the field immediately for modification and that replacement Inserters will be shipped upon receipt of completed acknowledgement form and RMA request for part return. For questions call 978-232-3990. |
Quantity in Commerce |
61 individual inserter assemblies |
Distribution |
Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama |
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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