Spinal Solutions Recalls 45 mm Screws Due to Missing Instructions
Spinal Solutions is recalling 24 units of 45 mm screws 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 hazard is a documentation issue (missing instructions) rather than a physical defect or contamination, fitting the criteria for minor labeling/documentation errors.
Plain-English summary
Spinal Solutions, LLC is recalling 24 units of 45 mm screws (Item #BG7045). The recall was initiated because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
The company distributes spinal fixation devices in loaner bins or on consignment. The affected products were distributed nationwide in the states of Mississippi, Texas, Nevada, California, Maryland, and Wisconsin.
Physicians and healthcare facilities should stop using the affected screws and contact Spinal Solutions for further instructions regarding the missing documentation.
The recalled product
- Product
- 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
- Manufacturer
- Spinal Solutions, LLC
- Hazard
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item #BG7045
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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