Device product
50 mm Rod, Item #BG1650 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.
Z-1413-2013
Product summary
- Event
- Event 64586
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 units
- Official record key
device-enforcement:Z-1413-2013
Official wording
Reason: 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.
Code information: Item #BG1650
Distribution pattern: USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
Derived failure modes
-
Unknown
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.