FDA-Device2013-06-05Class II
60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Spinal Solutions, LLC
Hazard
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Sold states
USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
Affected count
72 units
Manufactured in
26157 Jefferson Ave, N/A, Murrieta, CA, United States
Products
60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1414-2013Don't want to check this manually?
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