Recall Z-1869-2013 ยท FSM Tray, Surgical, Instrument
SpineFrontier, Inc.
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients
| Date | Aug 1, 2013 (initiated Oct 5, 2012) |
| Status | Terminated |
| Reason | Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws. |
| Root cause | Device Design |
| Action | The firm, SpineFrontier, sent an Advisory Notice entitled "URGENT May 1, 2013, PedFuse Screw Caddy Removal" dated May 1, 2013 to their consignees/customers. The notice described the product, problem and action to be taken. Consignees/customers were informed that a removal has been initiated to remove the parts from the field to ensure that all sets contain correctly marked screw caddies. Consignees/customers wre instructed to complete and return the URGENT PedFuse Screw Caddy Removal ACKNOWLEDGEMENT FORM via fax to: SpineFrontier, Inc., 978-232-3991 or email: customerservice@spinefrontier.c |
| Quantity | 11 caddies |
| Distribution | US distribution in states of: CO, DC, MA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.