Trilliant Surgical Recalls Hammertoe Implant Instructions for Use
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for its Two-Step Hammertoe 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 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 the Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols for the Two-Step Hammertoe Implant System, Model 214-00-001. The recall involves 17 systems. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
The recall was initiated because the IFU and protocols were updated with revised dry time parameters. The source text notes that this recall of the IFU occurred in 2018. The affected documents are IFUs previous to Document #900-01-008 Rev. N and Cleaning and Sterilization Protocols previous to Document #900-06-016 Rev. C.
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. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
- Manufacturer
- Trilliant Surgical, LLC
- Hazard
- Affected units
- 17
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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