Trilliant Surgical 3S Hemi Toe Implant Instructions for Use Recall
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for the 3S Hemi Toe Implant System 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 involves updated documentation for dry time parameters without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Trilliant Surgical, LLC is recalling the Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols for the 3S Hemi Toe Implant System, Model 111-00-001. The recall involves 9 systems and affects documentation versions prior to Document #900-01-009 Rev. I and Document #900-06-008 Rev. H.
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 documentation was 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. Users should refer to the updated documents for the correct dry time parameters.
The recalled product
- Product
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
- Manufacturer
- Trilliant Surgical, LLC
- Hazard
- Affected units
- 9
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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