Recall Z-1665-2013 ยท LXH Orthopedic Manual Surgical Instrument
SpineFrontier, Inc.
S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA
| Date | Jul 5, 2013 (initiated May 24, 2013) |
| Status | Terminated |
| Reason | The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small. |
| Root cause | Device Design |
| Action | Spine Frontier sent an Urgent Advisory Notice letter dated On June 7, 2013 to all consignees via email. The letter identified the affected product, problem and actions to be taken. The letter informed consignees that a modification has been implemented to the Outer Sleeve component of the S-LIFT Inserter and that SpineFrontier has initiated removal of the affected product from the field.. An acknowledgement form is to be signed and returned from each recipient of the Advisory Notice. Upon receipt of the acknowledgement form and RMA request for part return, replacement parts will be shipped. F |
| Quantity | 12 devices |
| Distribution | USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA |
| 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 |