Spinal Solutions Recalls Loaner Bins Due to Missing Surgical Instructions
Spinal Solutions is recalling 35 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 injuries, illnesses, or hospitalizations. The hazard is a documentation failure (missing instructions) rather than a direct physical defect, fitting the criteria for a moderate severity score.
Plain-English summary
Spinal Solutions, LLC is recalling 35 units of loaner bins and sterilization trays used for spinal implants and instruments. The recall was initiated because the company failed to provide directions for use and surgical techniques to every physician for every surgery.
The affected products include specific spinal fixation devices (14 x 11 x 6mm through 14 x 11 x 12mm, 7 deg) distributed in loaner bins or on consignment. The company has decided to provide these instructions electronically on its website and created a label to inform users of this resource.
The products were distributed nationwide in the states of Mississippi, Texas, Nevada, California, Maryland, and Wisconsin. Physicians and facilities using these loaner bins should verify that they have access to the electronic directions for use and surgical techniques available on the Spinal Solutions website.
The recalled product
- Product
- 14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The c
- Manufacturer
- Spinal Solutions, LLC
- Affected units
- 35
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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