RecallRadar

FDA Device recall Z-2086-2013

Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm

On 2013-09-04 the FDA classified a Class II recall of Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm by Alphatec Spine, citing the firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bon….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2086-2013
ClassificationClass II
Statusterminated
Initiated2013-06-28
Published2013-09-04
Last updated2026-09-13 11:53 UTC
CompanyAlphatec Spine
DistributionUS

Product

Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.

Reason

The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver.

Identifiers

code_infoPart Number 73875-40. Lots Affected: 647289, 648923, 649244, 649556, 649813, 650040, 650262, 650589.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2086-2013%22

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