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U.S. Department of Health and Human Services

Class 2 Device Recall SLIFT

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  Class 2 Device Recall SLIFT see related information
Date Initiated by Firm May 17, 2013
Date Posted July 05, 2013
Recall Status1 Terminated 3 on May 17, 2016
Recall Number Z-1664-2013
Recall Event ID 65432
510(K)Number K092815  
Product Classification Tray, surgical, instrument - Product Code FSM
Product BASE, S-LIFT Instrument Case

Product Usage:
System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
Code Information Lot/Serial Numbers: 7201.007 and 7201.007-1
Recalling Firm/
Manufacturer		 SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly MA 01915-6516
For Additional Information Contact Helen Moon
978-232-3990
Manufacturer Reason
for Recall		 The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
FDA Determined
Cause 2		 Component design/selection
Action Spine Frontier sent an Urgent Advisory Notice letter dated On June 7, 2013 to all consignees via email. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a modification has been implemented for the improved durability of S-LIFT Case Brackets and that SpineFrontier has initiated removal of these cases from the field. An acknowledgement form is to be signed and returned from each recipient of the Advisory Notice. Upon receipt of the acknowledgement form and RMA request for part return, replacement parts will be shipped. For questions call 978-232-3990.
Quantity in Commerce 12
Distribution USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = FSM and Original Applicant = SPINEFRONTIER, INC.
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