Reported Mar 22, 2017 · Terminated
L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar…
Kiscomedica S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kiscomedica S.A. · Parc Technologique - 2 Place · Saint Priest, N/A · N/A
Is this the product you have?
- L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France
- Product UsageThe 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
- Lot codes and dates
- Batch number15486
- Amount recalled
- 13 units
Where it was sold
- Nationwide
- MO
Why it was recalled
Firm received a complaint of the tip holder breaking during use.
This product could cause temporary or reversible health problems — stop using it.
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