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U.S. Department of Health and Human Services

Class 2 Device Recall InSpan Inserter

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 Class 2 Device Recall InSpan Insertersee related information
Date Initiated by FirmMay 07, 2013
Date PostedJuly 05, 2013
Recall Status1 Terminated 3 on January 11, 2016
Recall NumberZ-1666-2013
Recall Event ID 65442
Product Classification Screwdriver - Product Code HXX
ProductInSpan 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.
Code Information Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R
FEI Number 3005977257
Recalling Firm/
Manufacturer		 SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly MA 01915-6516
For Additional Information ContactHelen Moon
978-232-3990
Manufacturer Reason
for Recall		Potential for set screw to be come deformed.
FDA Determined
Cause 2		Device Design
ActionSpine 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 Commerce61 individual inserter assemblies
DistributionWorldwide 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 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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