Alphatec Recalls Leucadia Autolok Pedicle Screw System Due to Tolerancing Issue
Alphatec Spine is recalling the Leucadia Autolok Polyaxial Pedicle Screw System because a tolerancing issue may prevent the rod from locking rigidly, potentially compromising spinal stability.
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 involves a risk-of-harm product where the device may fail to provide a rigid construct under loading, but no injuries have been reported, fitting the 'High' severity criteria.
Plain-English summary
Alphatec Spine, Inc. is recalling the Leucadia Autolok Polyaxial Pedicle Screw System, a medical device intended to help provide correction, immobilization, and stabilization of spinal segments. The recall involves 1,814 units that were distributed nationwide.
The recall was initiated due to a tolerancing issue where the flange of the set screw may interfere with the top of the screw head before the rod is fully locked. If this occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date, there have been no reports of patient injury or adverse events.
Healthcare providers and patients who have received this device should contact Alphatec Spine for further instructions on how to proceed with the recall.
The recalled product
- Product
- Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
- Manufacturer
- Alphatec Spine, Inc.
- Affected units
- 1,814
Distribution
Distributed nationwide across the United States.
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