Genesys Binary Screwdriver Recalled Due to Threaded Shaft Breakage
Genesys Orthopedics is recalling 120 Binary Screwdrivers because the threaded inner shaft tip can break off during cervical screw insertion.
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 hazard involves a mechanical failure (shaft breakage) in a surgical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Genesys Orthopedics Systems, LLC is recalling 120 units of the Genesys Spine Binary Screwdriver (GCP221). This device is a component of the Binary Anterior Cervical Plating System, which is intended for anterior screw fixation to the cervical spine in skeletally mature patients.
The recall was initiated because an unanticipated technique for cervical screw insertion caused the tip of the threaded inner shaft to break off. The affected lot numbers are 10923, 109231, 11476, 11993, and WT20150630A.
The affected units were distributed in the United States to the states of Florida, Texas, New York, Illinois, Georgia, Alabama, Massachusetts, and Missouri. Healthcare facilities and consumers who possess these devices should stop using them and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an…
- Manufacturer
- Genesys Orthopedics Systems, LLC
- Affected units
- 120
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 (5)
- Lot numbers: 10923
- 109231
- 11476
- 11993
- WT20150630A
Distribution
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