Spinal Solutions Recalls Loaner Bins Due to Missing Surgical Instructions
Spinal Solutions is recalling loaner bins and sterilization trays for spinal implants 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. The hazard involves missing documentation (directions for use) rather than a physical defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Spinal Solutions, LLC is recalling 16 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 Fang Screws (20mm) and Fang Plates (21mm), identified by item numbers FP1220 and FP1221. These items were distributed nationwide in the United States, specifically in the states of Mississippi, Texas, Nevada, California, Maryland, and Wisconsin.
Spinal Solutions has decided to provide directions for use and surgical techniques electronically on the company's website. The company created a label to inform users of the existence of these websites and the information they contain. Physicians and facilities using these loaner bins should verify that they have access to the current electronic instructions.
The recalled product
- Product
- Fang Screw 20mm Fang Plate 21mm 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…
- Manufacturer
- Spinal Solutions, LLC
- Hazard
- Affected units
- 16
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 # FP1220 FP1221
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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