Alphatec Recalls Illico Ti Cannulated Polyaxial Screws Due to Manufacturing Defect
Alphatec Spine is recalling specific lots of Illico Ti Cannulated Polyaxial Screws because an off-center hole may prevent guide wires from passing through during surgery.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a potential risk of surgical device malfunction without reporting specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alphatec Spine, Inc. is recalling 333 units of the Illico Ti Cannulated Polyaxial Screw 7.5mm x 40mm. The recall affects specific lots identified by part number 73875-40, including lots 647289, 648923, 649244, 649556, 649813, 650040, 650262, and 650589.
The recall was initiated due to an off-center cannulation hole at the proximal end of the bone screw. This manufacturing defect creates a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver as intended.
The affected devices were distributed worldwide, including nationwide in the United States and in Spain, France, and Japan. 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.
The recalled product
- 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…
- Manufacturer
- Alphatec Spine, Inc.
- Affected units
- 333
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 (8)
- Part Number 73875-40. Lots Affected: 647289
- 648923
- 649244
- 649556
- 649813
- 650040
- 650262
- 650589.
Distribution
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