Kiscomedica S.A.: Medical Device Recall in 2017 - (Recall #: Z-1461-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 11, 2017

Date Posted: March 22, 2017

Recall Number: Z-1461-2017

Event ID: 76494

Reason for Recall:

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

Status: Terminated

Product Quantity: 13 units

Code Information:

Batch number: 15486

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated