Recall Z-1565-2014 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
SpineFrontier, Inc.
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
| Date | May 7, 2014 (initiated Dec 23, 2011) |
| Status | Terminated |
| Reason | It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma |
| Root cause | Device Design |
| Action | Spine Frontier sent an Urgent Notification dated December 23, 2011, consignees. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached acknowledgement form. For questions call 866-914-7717 |
| Quantity | 30 devices |
| Distribution | US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO |
| 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 |