Trilliant Surgical Recalls Out-of-Specification Fibula Plates
Trilliant Surgical Ltd. is recalling 28 units of VL Gridlock Fibula Plates because insufficient thread depth may limit locking screw functionality.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that compromises the locking mechanism, posing a risk of harm during surgical procedures, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Trilliant Surgical Ltd. is recalling 28 units of 7, 9, and 11 Hole VL Gridlock Fibula Plates (Part # 300-60-001, 300-60-002, and 300-60-003). These non-sterile, single-use medical devices are intended for use in trauma and reconstructive procedures in small bones.
The recall is due to the affected parts being out of specification. Specifically, the thread depth of the screw holes is insufficient, which potentially limits the ability to engage and lock with associated mating locking screws, resulting in the loss of optimal locking screw functionality.
The affected lots are TSL002595, TSL002596, and TSL002597. The products were distributed in the United States to the states of Florida, Ohio, New Jersey, Minnesota, Wisconsin, New Mexico, and California. Healthcare providers and facilities should stop using these specific lots and contact the manufacturer for further instructions.
The recalled product
- Product
- 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive pr
- Manufacturer
- Trilliant Surgical Ltd.
- Affected units
- 28
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 (3)
- Lots: TSL002595
- TSL002596
- TSL002597
Distribution
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