Trilliant Surgical Twist Sublatar Implant System Instructions for Use Recall
Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Twist Sublatar 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 Twist Sublatar Implant System, Model 112-00-001. The recall involves 4 systems total for both Twist Sublatar and Disco Sublatar. The affected documents are IFUs previous to Document #900-01-003 Rev. M and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C.
The recall was initiated to update the documents with revised dry time parameters. This recall of the IFU occurred in 2018. The products were distributed to various US states, including AZ, CA, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, MO, MT, ND, NE, NH, NJ, OH, OK, PA, SD, TN, TX, VA, WA, WI, and WY, as well as Puerto Rico. There was also foreign distribution to Australia, India, Italy, Panama, and Turkey.
Healthcare facilities and users should contact Trilliant Surgical, LLC to obtain the updated Instructions for Use and Surgical Cleaning and Sterilization Protocols. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
The recalled product
- Product
- Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
- 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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