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U.S. Department of Health and Human Services

Class 2 Device Recall SpineFrontier SLift Lock Shaft Inserter

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  Class 2 Device Recall SpineFrontier SLift Lock Shaft Inserter see related information
Date Initiated by Firm December 23, 2011
Date Posting Updated May 07, 2014
Recall Status1 Terminated 3 on May 20, 2014
Recall Number Z-1565-2014
Recall Event ID 63145
510(K)Number K092815  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
Code Information S-Lift Lock Shaft Part number; SI50001, Revisions: A, B, Lots: 42613, 2478901R, 42615, 7625701
Recalling Firm/
Manufacturer
SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly MA 01915-6516
For Additional Information Contact
866-914-7717
Manufacturer Reason
for Recall
It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
FDA Determined
Cause 2
Device Design
Action Spine Frontier sent an Urgent Notification dated December 23, 2011, consignees. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached acknowledgement form. For questions call 866-914-7717
Quantity in Commerce 30 devices
Distribution US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
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 = MAX and Original Applicant = SPINEFRONTIER, INC.
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