FDAFDA · Food and drugs·Recall number Z-0967-2013
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.
Published March 27, 2013 · Recall initiated: July 6, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alphatec Spine, Inc.
- Distributor
- Worldwide Distribution - USA including CO and NC; Internationally to Belgium.
- Lot
- Lot # 635436; Part #73601-110
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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