Trilliant Surgical Recalls Non-Sterile Cannulated Screw Countersinks
Trilliant Surgical Ltd. is recalling 102 units of non-sterile cannulated screw countersinks because their cutting efficiency was out of specification.
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. The hazard is a performance defect (cutting efficiency out of specification) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Trilliant Surgical Ltd. is recalling 102 units of 2.0/2.4 and 3.0/4.0 Cannulated Screw Countersinks (Part # 210-24-002 and Part # 210-40-002). These non-sterile instruments are part of the Tiger Cannulated Screw Fixation System, which is intended for the fixation of fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand and foot. The affected units are designated for single use only.
The recall was initiated because the cutting efficiency of the countersinks was out of specification. The affected lot numbers are 1362-01 and 1364-01. The products were distributed nationwide in the United States, specifically in the states of NY, CT, TN, TX, OH, IN, LA, NC, MO, MN, GA, FL, SC, WA, WI, IA, PA, CA, ND, OK, NJ, MI, and MD.
Healthcare facilities and consumers who possess these specific instruments should stop using them immediately. Users should contact Trilliant Surgical Ltd. for instructions on how to return the affected units.
The recalled product
- Product
- 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis…
- Manufacturer
- Trilliant Surgical Ltd.
- Hazard
- Affected units
- 102
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 (1)
- Lot numbers 1362-01 and 1364-01
Distribution
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