Ebi Solitaire-35 Spinal Fusion Device Recalled for Screw Complaints
Ebi, LLC is recalling 1,730 units of the Solitaire-35 PEAK Solitaire Anterior Spinal System due to complaints regarding one of the three screws driving through the cage.
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 text does not report any specific injuries, illnesses, or fatalities, which aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ebi, LLC is recalling 1,730 units of the Solitaire-35 PEAK Solitaire Anterior Spinal System. This product is an intervertebral body fusion device used in anterior spinal surgery. The recall was initiated after several complaints were recorded regarding one of the three screws driving through the cage of the implant.
The affected units were distributed nationwide in the United States, specifically in the states of California, Georgia, Indiana, Kentucky, Missouri, New York, Oregon, Texas, and Wisconsin. The recall covers specific catalog numbers and lot codes manufactured between October 2022 and May 2022, as detailed in the agency's structured product information.
This is an FDA Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries, illnesses, or fatalities associated with this recall. Healthcare providers and patients should contact Ebi, LLC for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
- Manufacturer
- Ebi, Llc
- Affected units
- 1,730
Distribution
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