Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
L-Varlock Cage/Trial Implant Holder Recalled by Kiscomedica S.A. Due to Firm received a complaint of the tip holder...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Kiscomedica S.A. directly.
Affected Products
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.
Quantity: 13 units
Why Was This Recalled?
Firm received a complaint of the tip holder breaking during use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Kiscomedica S.A.
Kiscomedica S.A. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report