Trilliant Surgical Recalls Instructions for Use for Cannulated Screw Systems
Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for two cannulated screw systems to update dry time parameters.
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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Trilliant Surgical, LLC is recalling the Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols for the Trilliant Surgical Ltd Tiger Large Cannulated Screw System (Model 215-00-001) and the Trilliant Surgical Ltd Large Cannulated Headless Screw System (Model 215-00-001). The recall involves 4 systems.
The recall was initiated to update the documents with revised dry time parameters. The source text notes that this recall of the IFU occurred in 2018. The affected documents are those previous to specific revision numbers: for the Tiger Large Cannulated Screw System, IFUs previous to Document #900-01-010 Rev. I and Cleaning and Sterilization Protocols previous to Document #900-06-009 Rev. F; and for the Large Cannulated Headless Screw System, IFUs previous to Document 900-01-014 Rev G and Cleaning and Sterilization Protocols previous to Document #900-06-012 Rev. D.
The products were distributed to 29 US states and Puerto Rico, as well as to Australia, India, Italy, Panama, and Turkey. The distribution included government channels but no military distribution. The source text does not specify the actions consumers or healthcare providers should take.
The recalled product
- Product
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless Screw System, Model 215-00-001. The firm name on the…
- Manufacturer
- Trilliant Surgical, LLC
- Hazard
- Affected units
- 4
Distribution
Part of a larger recall action
This product is one of 10 recalled by Trilliant Surgical, 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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