Alphatec ILLICO Spinal Rods Recalled for Incorrect Length Marking
Alphatec Spine is recalling 7 ILLICO spinal rods that were laser-etched as 110mm but are actually 100mm long.
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, and the hazard is a labeling error (incorrect length marking) rather than a direct contamination or structural failure, fitting the Moderate criteria for minor labeling errors.
Plain-English summary
Alphatec Spine, Inc. is recalling seven ILLICO Straight CP TI Rods (Reference #73601-110) due to a manufacturing labeling error. The rods were incorrectly laser-etched to indicate a length of 110mm, but they were actually manufactured to be 100mm in length.
The affected product is part of the ILLICO MIS Posterior Spinal Fixation System, which is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization. The recall covers units distributed worldwide, including the United States (specifically Colorado and North Carolina) and Belgium.
Healthcare providers and patients should verify the actual length of the rods against the laser etching before use. If the rods have already been implanted, providers should consult with Alphatec Spine regarding the discrepancy. The agency has classified this as a Class II recall.
The recalled product
- 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…
- Manufacturer
- Alphatec Spine, Inc.
- Hazard
- Affected units
- 7
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)
- Lot # 635436
- Part #73601-110
Distribution
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