Recall Z-1461-2017 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Kiscomedica S.A.
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
| Date | Feb 27, 2017 (initiated Jan 11, 2017) |
| Status | Terminated |
| Reason | Firm received a complaint of the tip holder breaking during use. |
| 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 | 13 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of MO and country of Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080537 | L-VARLOCK Kiscomedica S.A., Jun 30, 2008 |