Recall Z-0967-2013 ยท KWP Appliance, Fixation, Spinal Interlaminal
Alphatec Spine, Inc.
ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
| Date | Mar 18, 2013 (initiated Jul 6, 2011) |
| Status | Terminated |
| Reason | The rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length. |
| Root cause | Process control |
| Action | Alphatec Spine sent an Urgent Medical Device Recall letter dated July 6, 2011, to all affected customers. This notification described the product, problem and actions to be taken. The consignees were instructed to review their inventory to verify the affected device; abstain from use; immediately contact Alphatec Spine Sales Administration (salesadministration@alphatecspine.com) for instructions on how to return this affected product; and complete, sign and return confirmation form to Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad, CA 92008. If you have any questions, call 760-431-9286. |
| Quantity | 7 |
| Distribution | Worldwide Distribution - USA including CO and NC; Internationally to Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042673 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec/Nexmed, Oct 27, 2004 |