Trilliant Surgical Recalls Instructions for Use for Tiger Screw Systems
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for Tiger 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 and involves a documentation update (revised dry time parameters) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Trilliant Surgical, LLC is recalling Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols for the Trilliant Surgical Tiger Cannulated Screw System (Model 210-00-001) and the Combination Tiger/Tiger Headless Cannulated Screw System (Model 210-00-101). The recall involves 170 systems. The documents being recalled are those previous to Document #900-01-002 Rev. P and Document #900-06-007 Rev. F.
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 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. No specific instructions for consumer action are provided in the source text beyond the identification of the affected document revisions.
The recalled product
- Product
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant…
- Manufacturer
- Trilliant Surgical, LLC
- Hazard
- Affected units
- 170
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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