Spinal Solutions Recalls Copperhead IBFD Loaner Bins Due to Missing Instructions
Spinal Solutions is recalling Copperhead IBFD loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 'Moderate' criteria for minor labeling/documentation errors.
Plain-English summary
Spinal Solutions, LLC is recalling 24 units of Copperhead IBFD, Large Neutral, loaner bins and sterilization trays. The affected sizes range from 6mm to 11mm, with item numbers C5006 through C5011. These devices are used for spinal fixation.
The recall was initiated because the directions for use and surgical techniques were not being provided to every physician and for every surgery. Spinal Solutions had decided to provide this information electronically on their website and created a label to inform users of the website's existence, but the physical instructions were not consistently distributed with the loaner bins.
The products were distributed nationwide in the United States, specifically in the states of Mississippi, Texas, Nevada, California, Maryland, and Wisconsin. Physicians and healthcare facilities should stop using the affected loaner bins and sterilization trays and contact Spinal Solutions for further instructions.
The recalled product
- Product
- Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm Product Usage: Spinal Solutions distributes a…
- Manufacturer
- Spinal Solutions, LLC
- Category
- Medical Device — Spinal Fixation
- 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 # C5006 C5007 C5008 C5009 C5010 C5011
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.
See all 10 products in this recall →Related recalls
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