Z-0967-2013Class II

ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc...

Name: 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...
Creator: Alphatec Spine, Inc.
Published: 2011-07-06
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2011-07-06 / Terminated / root cause: manufacturing process

FDA source

Alphatec Spine, Inc. began a recall of 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... on 2011-07-06. FDA classified it as Class II and gives the reason as "The rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0967-2013
Classification: Class II
Status: Terminated
Initiated: 2011-07-06
Posted: 2013-03-18
Terminated: 2013-03-20
Recalling firm: Alphatec Spine, Inc.
Product: 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.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
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.
Root cause tag: manufacturing process
FDA 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 ([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.
Quantity in commerce: 7
Distribution: Worldwide Distribution - USA including CO and NC; Internationally to Belgium.
Product codes and lots: Lot # 635436; Part #73601-110

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0967-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0967-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-18

Product code KWP

K042673Class IIZodiac Polyaxial Spinal Fixation SystemAlphatec/Nexmed / cleared 2004-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)