Recall Z-1664-2013 ยท FSM Tray, Surgical, Instrument
SpineFrontier, Inc.
BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
| Date | Jul 5, 2013 (initiated May 17, 2013) |
| Status | Terminated |
| Reason | The S-LIFT Instrument Case contained a bracket with peeling nylon coating. |
| Root cause | Component design/selection |
| 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 customers that a modification has been implemented for the improved durability of S-LIFT Case Brackets and that SpineFrontier has initiated removal of these cases 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. For quest |
| Quantity | 12 |
| Distribution | USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN. |
| 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 |