Trilliant Tiger Screw Sterilization Tray Base Assembly Recall for Printing Error
Trilliant Surgical Ltd. is recalling Tiger Screw Sterilization Tray Base Assemblies due to a printing error on k-wire description markings.
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 minor labeling error (printing error) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Trilliant Surgical Ltd. is recalling four lots of Tiger Screw Sterilization Tray Base Assemblies, Model 210-00-001, Revision N and O. The affected units were released to the field with a printing error where the k-wire description markings indicate diameters of 0.45 and 0.35 instead of the correct 0.045" and 0.035".
The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device. The recall involves 50 units distributed nationwide. The affected lot numbers are TSL003191, TSL003637, TSL004101, and TSL004395.
This recall is classified as Class II by the FDA. Users should check their inventory for the specific model, revision, and lot numbers listed above and stop using the affected components.
The recalled product
- Product
- Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
- Manufacturer
- Trilliant Surgical Ltd.
- Hazard
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: TSL003191
- TSL003637
- TSL004101
- TSL004395
Distribution
Distributed nationwide across the United States.
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