Z-1461-2017Class II

L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France

Name: Z-1461-2017 L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France
Creator: Kiscomedica S.A.
Published: 2017-01-11
License: https://open.fda.gov/license/

Kiscomedica S.A. / initiated 2017-01-11 / Terminated / root cause: manufacturing process

FDA source

Kiscomedica S.A. began a recall of L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral... on 2017-01-11. FDA classified it as Class II and gives the reason as "Firm received a complaint of the tip holder breaking during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1461-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-11
Posted: 2017-02-27
Recalling firm: Kiscomedica S.A.
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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Firm received a complaint of the tip holder breaking during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 13 units
Distribution: Worldwide Distribution - US Nationwide in the states of MO and country of Switzerland.
Product codes and lots: Batch number: 15486

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1461-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1461-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-14

Product code MAX

K080537Class IIL-VarlockKiscomedica S.A. / cleared 2008-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)