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U.S. Department of Health and Human Services

Class 2 Device Recall LVarlock Cage/Trial Implant Holder

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 Class 2 Device Recall LVarlock Cage/Trial Implant Holdersee related information
Date Initiated by FirmJanuary 11, 2017
Date PostedFebruary 27, 2017
Recall Status1 Terminated 3
Recall NumberZ-1461-2017
Recall Event ID 76494
510(K)NumberK080537 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductL-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Code Information Batch number: 15486
FEI Number 3005440746
Recalling Firm/
Manufacturer		 Kiscomedica S.A.
Parc Technologique - 2 Place
Berthe Morisot
Saint Priest France
For Additional Information ContactJ.D. Webb
512-692-3699
Manufacturer Reason
for Recall		Firm received a complaint of the tip holder breaking during use.
FDA Determined
Cause 2		Process control
ActionManufacturer's Field Safety Corrective Action Report was submitted to ANSM (French Health Products Safety Agency) on January 11, 2017. The Field Safety Notice was sent to U.S. Consignee on January 18, 2017. The letter identified the affected product, problem and actions to be taken.
Quantity in Commerce13 units
DistributionWorldwide Distribution - US Nationwide in the states of MO and country of Switzerland.
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.
510(K) Database510(K)s with Product Code = MAX
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