Z-1409-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2013
- Initiation Date
- February 20, 2013
- Termination Date
- March 26, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
45 mm Screw, Item #BG7045 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.
Reason for Recall
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.
Distribution Pattern
USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
Code Information
Item #BG7045