Genesys Spine Recalls Circular Lock Screws Due to Material Error
Genesys Orthopedics Systems is recalling 642 Circular Lock Screws from the TiLock Pedicle Screw System because a portion of the lot was manufactured with stainless steel instead of the specified titanium alloy.
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 medical device with a material defect (stainless steel instead of titanium) where no injuries or illnesses have been reported, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Genesys Orthopedics Systems, LLC is recalling 642 Circular Lock Screws, part number G826, lot number 11406. These devices are part of the Genesys Spine TiLock Pedicle Screw System, which is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
The recall was initiated after the supplier, MK Precision, notified Genesys Spine that a portion of the screws in lot 11406 were manufactured using stainless steel in the center post instead of the specified titanium alloy. The source text indicates that less than 20% of the screws in the lot were affected by this material substitution.
The devices were distributed nationwide, including in Nevada, California, New York, Missouri, Texas, Florida, New Jersey, Georgia, and Tennessee. The source text does not specify any reported illnesses, injuries, or deaths associated with the use of these devices.
The recalled product
- Product
- Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to…
- Manufacturer
- Genesys Orthopedics Systems, LLC
- Hazard
- Affected units
- 642
Distribution
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