FDAFDA · Food and drugs·Recall number Z-1461-2017
L-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.
Published March 22, 2017 · Recall initiated: January 11, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Firm received a complaint of the tip holder breaking during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kiscomedica S.A.
- Distributor
- Worldwide Distribution - US Nationwide in the states of MO and country of Switzerland.
- Lot
- Batch number: 15486
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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