L-Varlock Cage/Trial Implant Holder — Class II medical device recall Z-1461-2017
Terminated recall by Kiscomedica S.A., reported 2017-03-22, distributed nationwide. Firm received a complaint of the tip holder breaking during use.
| Recall number | Z-1461-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kiscomedica S.A., Saint Priest, N/A, France |
| Recall initiated | 2017-01-11 |
| Classified | 2017-03-14 |
| Reported by FDA | 2017-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH |
| Quantity | 13 units |
| Lot numbers | 15486 |
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 for recall
Firm received a complaint of the tip holder breaking during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1461-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.