Trilliant Surgical Recalls Cannulated Headless Screws Due to Labeling Errors
Trilliant Surgical Ltd. is recalling 11 units of Model 208-70-110 cannulated headless screws because they bear incorrect part and lot numbers on the labels.
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, but the source text explicitly states that no injuries or illnesses have been reported. The hazard is limited to labeling errors (incorrect part and lot numbers), which fits the criteria for a moderate severity score involving minor labeling errors or low-risk issues without reported harm.
Plain-English summary
Trilliant Surgical Ltd. is recalling 11 units of Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screws (7 x 110 mm). The recall was initiated because the screws were identified as having incorrect part and lot numbers marked on them.
The part number on the label incorrectly indicated a length of 115 mm rather than the actual 110 mm. Additionally, the lot number on the label incorrectly indicated TSL003765 rather than the correct lot number, TSL003721. The affected units were distributed to locations in California, Arizona, Wisconsin, Florida, New Jersey, and Ohio.
This is a Class II recall. No injuries or illnesses have been reported in connection with the use of these devices. Healthcare providers and patients should stop using the affected screws and contact Trilliant Surgical Ltd. for further instructions.
The recalled product
- Product
- Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"
- Manufacturer
- Trilliant Surgical Ltd.
- Hazard
- Affected units
- 11
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 TSL003721
Distribution
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