Ebi Recalls Cypher MIS Screw System Due to Screw Head Splay
Ebi, LLC is recalling 427 units of the Cypher MIS Screw System because several complaints reported screw head splay.
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 structural defect (screw head splay) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ebi, LLC is recalling 427 units of the Cypher MIS Screw System, a non-cervical spinal fixation device manufactured by Biomet Spine. The recall involves specific lots of the Screw Tower, Rod Reduce, and Counter Torque components.
The recall was initiated after several complaints were reported to the manufacturer indicating that the devices exhibited screw head splay. The affected units were distributed nationwide in the United States, including the states of Indiana, Maryland, Mississippi, North Carolina, Ohio, Pennsylvania, South Carolina, and Texas.
Healthcare providers and facilities that have received these devices should stop using them and contact Ebi, LLC for further instructions on the recall process.
The recalled product
- Product
- Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
- Manufacturer
- Ebi, Llc
- Category
- Medical Device — Spinal Fixation
- Hazard
- Affected units
- 427
Distribution
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