Trilliant Surgical Recalls Instructions for Use for Tiger Screw Systems
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for Tiger 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 recall.
Plain-English summary
Trilliant Surgical, LLC is recalling the Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols for the Tiger Headless Cannulated Screw System (Model 212-00-001) and the Combination Tiger Cannulated/Tiger Headless Cannulated Screw System (Model 210-00-101). The recall involves 28 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 #900-01-004 Rev. P and Cleaning and Sterilization Protocols previous to Document #900-06-007 Rev. F. This recall of the IFU occurred in 2018.
The products were distributed to 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 government distribution but no military distribution. Foreign distribution occurred in Australia, India, Italy, Panama, and Turkey. The agency classification for this recall is Class II.
The recalled product
- Product
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combination Tiger Cannulated/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name…
- Manufacturer
- Trilliant Surgical, LLC
- Hazard
- Affected units
- 28
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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