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Recall Observatory FDA recall evidence

Device product

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.

Z-1461-2017

January 11, 2017

Class II

Product summary

Firm
Kiscomedica S.A.
Event
Event 76494
Status
Terminated
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-1461-2017

Official wording

Reason: Firm received a complaint of the tip holder breaking during use.

Code information: Batch number: 15486

Distribution pattern: Worldwide Distribution - US Nationwide in the states of MO and country of Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm received a complaint of the tip holder breaking during use.