Spinal Solutions Recalls Loaner Bins and Sterilization Trays for Missing Instructions
Spinal Solutions, LLC is recalling 56 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a documentation failure (missing instructions) rather than a direct physical defect or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Spinal Solutions, LLC is recalling 56 units of loaner bins and sterilization trays used for spinal implants and instruments. The recall was initiated because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
The affected products are spinal fixation devices distributed in loaner bins or on consignment. The specific item numbers involved are 10227-008 through 10227-014, corresponding to various dimensions of the devices. The company had decided to provide directions for use and surgical techniques electronically on its website and created a label to inform users of this information, but the recall indicates these materials were not consistently delivered.
The products were distributed nationwide in the United States, specifically in the states of Mississippi, Texas, Nevada, California, Maryland, and Wisconsin. Physicians and facilities using these loaner bins should verify that they have received the appropriate directions for use and surgical techniques for the specific devices in use.
The recalled product
- Product
- 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has de
- Manufacturer
- Spinal Solutions, LLC
- Affected units
- 56
Distribution
Part of a larger recall action
This product is one of 10 recalled by Spinal Solutions, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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