Recall Z-1461-2017— Kiscomedica S.A.

Name: FDA recall Z-1461-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-11

Class II · Terminated

Class II FDA medical device recall by Kiscomedica S.A., initiated 2017-01-11. It names one FDA 510(k) clearance: K080537. 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..

Recalling firm: Kiscomedica S.A.
Classification: Class II
Status: Terminated
Initiated: 2017-01-11
Firm location: Saint Priest, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K080537 — L-VARLOCKKiscomedica S.A.·cleared 2008-06-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.