The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0168-2013·Announced 2012-11-07

Alphatec Spine Recalls Illico MIS Posterior Fixation System Screws

Alphatec Spine is recalling 209 Illico MIS Posterior Fixation System screws because a guide-wire fit issue renders them nonfunctional.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the defect renders the screws 'nonfunctional' without reporting any injuries, illnesses, or adverse health consequences. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls where harm has not been reported.

Plain-English summary

Alphatec Spine, Inc. is recalling 209 units of the Illico MIS Posterior Fixation System, specifically certain Ti Cannulated Polyaxial Screws. The recall was initiated because the stainless steel guide-wire of the system did not completely fit or pass through the tip of these specific screws. This mechanical incompatibility renders the affected screws nonfunctional for their intended use in surgical spinal fixation.

The affected product codes are KW, MNI, and MNH. The specific part numbers and lot numbers involved include 7384S-30 (Lot 646501), 73845-35 (Lot 646502), 73845-40 (Lot 646503), 73845-45 (Lot 646504), 73855-35 (Lot 646510), 73865-30 (Lot 646515), 73865-35 (Lot 646516), 73865-40 (Lot 646517), 73865-45 (Lot 646542), 73865-50 (Lot 646543), 73875-35 (Lot 646546), 73875-45 (Lot 646548), and 73875-50 (Lot 646549).

The product was distributed nationwide, including in Arizona, Illinois, California, South Carolina, Tennessee, Texas, Georgia, Connecticut, New York, Florida, Oklahoma, Louisiana, Missouri, Nevada, and Utah. Healthcare providers and facilities that have received these specific lot numbers should stop using the affected screws and contact Alphatec Spine, Inc. for instructions on return or replacement.

The recalled product

Product
ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical…
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Orthopedic / Spinal Fixation
Hazard
Affected units
209

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Product Codes: KW
  • MNI

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

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