FDA-Device2013-10-09Class II
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Ebi, Llc
Hazard
Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
Sold states
Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI.
Affected count
1730 units
Manufactured in
399 Jefferson Rd, Parsippany, NJ, United States
Products
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2292-2013Don't want to check this manually?
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