Trilliant Surgical Small Joint Reaming System Instructions for Use Recall
Trilliant Surgical LLC is recalling Instructions for Use and Cleaning Protocols for the Small Joint Reaming System to update dry time parameters.
What this means for you
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 Small Joint Reaming System, Model 311-00-001. The recall involves two systems. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
The recall was initiated to update the documents with revised dry time parameters. The affected documents are IFUs previous to Document #900-01-012 Rev. F and Cleaning and Sterilization Protocols previous to Document #900-06-011 Rev. E. The source text notes that this recall of the IFU occurred in 2018.
The products were distributed to 28 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 consumers are provided in the source text.
The recalled product
- Product
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
- Manufacturer
- Trilliant Surgical, LLC
- Hazard
- Affected units
- 2
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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