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.
FDA Recall Z-0967-2013 · Posted 2013-03-18
Advertisement
Recalling FirmAlphatec Spine, Inc.
Recall StatusTerminated
Product CodeKWP
Date Initiated2011-07-06
Date Terminated2013-03-20
Product Quantity7
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.
Firm 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 ([email protected]) 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA including CO and NC; Internationally to Belgium.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement