L-Varlock Cage/Trial Implant Holder, Reference HD0060… recallZ-1461-2017 · Kiscomedica S.A. · initiated Jan 11, 2017
Class II Terminated All recalls posted in February 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Kiscomedica S.A. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Firm received a complaint of the tip holder breaking during use.
FDA root cause category: Process control
What the company is doing
Manufacturer's Field Safety Corrective Action Report was submitted to ANSM (French Health Products Safety Agency) on January 11, 2017. The Field Safety Notice was sent to U.S. Consignee on January 18, 2017. The letter identified the affected product, problem and actions to be taken.
Recall details
- Recall number
- Z-1461-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 11, 2017
- Posted by the FDA
- Feb 27, 2017
- Recalling firm
- Kiscomedica S.A.
- Quantity
- 13 units
- Product code
- MAX
- FDA submissions
- K080537
- Distribution
- Worldwide Distribution - US Nationwide in the states of MO and country of Switzerland.
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.
Code information (models, lots, serial numbers)
Batch number: 15486
Other devices under the same FDA submission
1 device cleared under K080537 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- L-Varlock Lumbar posterior cage W10 H9Kisco International · Intervertebral Fusion Device With Bone Graft, Lumbar2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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