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.
This recall has been terminated (originally issued March 18, 2013).
- Company
- Alphatec Spine, Inc.
- Recall Initiated
- July 6, 2011
- Posted
- March 18, 2013
- Terminated
- March 20, 2013
- Recall Number
- Z-0967-2013
- Quantity
- 7
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.
Distribution
Worldwide Distribution - USA including CO and NC; Internationally to Belgium.
Lot / Code Info
Lot # 635436; Part #73601-110
Root Cause
Process control
Action Taken
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.