Recall Z-1958-2013 ยท FSM Tray, Surgical, Instrument
SpineFrontier, Inc.
Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. System cases are designed to hold and secure all instrumentation to be used with a surgical system.
| Date | Aug 13, 2013 (initiated Apr 22, 2013) |
| Status | Terminated |
| Reason | Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles. |
| Root cause | Labeling design |
| Action | On 2/15/2013, SpineFrontier emailed distributors informing them that they needed specific parts returned to work towards completing the conversion of product graphics. |
| Quantity | 258 units (30 in distribution at the time of the recall) |
| Distribution | Worldwide Distribution-USA including the states of FL, OH, MA, and TX, and the countries of Mexico, and Dominican Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.