Spinal Solutions Recalls Set Screws Due to Missing Surgical Instructions
Spinal Solutions is recalling 106 Set Screws (Item #BG3010) 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. The hazard involves missing documentation (directions for use) rather than a physical defect or contamination, and no injuries or illnesses are reported, fitting the criteria for a moderate severity recall.
Plain-English summary
Spinal Solutions, LLC is recalling 106 units of Set Screws, Item #BG3010. 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 and intended to provide these instructions electronically via its website.
The affected products were distributed nationwide in the United States, specifically in the states of Mississippi, Texas, Nevada, California, Maryland, and Wisconsin. The recall is classified as Class II by the FDA. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Set Screw, Item #BG3010 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 cr
- Manufacturer
- Spinal Solutions, LLC
- Hazard
- Affected units
- 106
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 #BG3010
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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