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Ebi, Llc recalls Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Recalled October 9, 2013 · FDA recall Z-2292-2013 · Ebi
Hazard
Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant. · FDA Class II
Units
1730 units
Sold at
Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI.
Description
Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
Product
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Manufacturer(s)
Ebi, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →