Recall Z-0417-2013 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
SpineFrontier, Inc.
S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior
| Date | Nov 21, 2012 (initiated Aug 22, 2012) |
| Status | Terminated |
| Reason | When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides |
| Root cause | Labeling design |
| Action | Spine Frontier issued a Correction Notice Letter August 22, 2012 to all affected customers to update the Instructions for Use. The letter identified the affected product, problem and actions to be taken. Customers were Instructed to remove the Instructions for Use they currently have and replace them with the update. The letter instructs customers to complete and return the Response Form to 978-232-3990. |
| Quantity | 19 units |
| Distribution | US Nationwide including the states of: MA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092815 | S-LIF INTERVERTEBRAL BODY FUSION DEVICE Spinefrontier, Inc., Jun 30, 2010 |