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Spinal Solutions, LLC recalls 50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner
Recalled June 5, 2013 · FDA recall Z-1410-2013 · Spinal Solutions
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. · FDA Class II
Units
52 units
Sold at
USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
Description
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.
Product
50 mm Screw, Item #BG7050 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.
Manufacturer(s)
Spinal Solutions, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →