Spinal Solutions Recalls 40 mm Rods Due to Missing Surgical Instructions
Spinal Solutions is recalling 63 units of 40 mm Rods 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation issue (missing instructions) rather than a physical defect or contamination, and no injuries or illnesses are reported.
Plain-English summary
Spinal Solutions, LLC is recalling 63 units of 40 mm Rods (Item #BG1640). 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 has decided to provide these instructions electronically on 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 addresses a documentation issue where the physical or electronic instructions were not consistently available to the medical professionals using the devices.
Physicians and healthcare facilities should check their inventory for the 40 mm Rods (Item #BG1640) and ensure they have access to the current directions for use and surgical techniques available on the Spinal Solutions website.
The recalled product
- Product
- 40 mm Rod, Item #BG1640 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
- Category
- Medical Device — Spinal Fixation
- Hazard
- Affected units
- 63
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 #BG1640
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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