FDA Device recall Z-1461-2017
L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France
- FDA Device
- Class II
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class II recall of L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France by Kiscomedica, citing firm received a complaint of the tip holder breaking during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1461-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-11 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Kiscomedica |
| Distribution | US |
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.
Reason
Firm received a complaint of the tip holder breaking during use.
Identifiers
| code_info | Batch number: 15486 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1461-2017%22
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