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.
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 3/5 (High).
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…
- 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
Related recalls
Same manufacturer · Trilliant Surgical Ltd.
See all →- HighTrilliant Surgical Recalls Ratcheting Cannulated Driver Handles Due to Function Degradation
FDA (Devices) · 2018-07-11
- ModerateTrilliant Surgical Recalls Cannulated Driver Handles Due to Function Degradation
FDA (Devices) · 2018-07-11
- ModerateTrilliant Tiger Screw Sterilization Tray Base Assembly Recall for Printing Error
FDA (Devices) · 2017-01-18
- ModerateTrilliant Surgical Recalls Cannulated Headless Screws Due to Labeling Errors
FDA (Devices) · 2016-11-23
- HighTrilliant Gridlock Screw Driver Bits Recalled for Out-of-Specification Dimensions
FDA (Devices) · 2015-09-16
Same hazard · functional defect
See all →- ModerateSunMed Tracheal Tube Recalled Due to Suction Catheter Passage Issues
FDA (Devices) · 2026-09-23
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
Similar recalls
- HighTrilliant Gridlock Screw Driver Bits Recalled for Out-of-Specification Dimensions
FDA (Devices) · 2015-09-16
- HighA.L.P.S. mvX Fibula Plate Recall: Locking Screw Malfunction During Surgery
FDA (Devices) · 2025-03-05
- SevereTrilliant Gridlock Ankle Screw Driver Bit Recalled for Specification Defect
FDA (Devices) · 2020-01-22
- HighOrthopedic fibula plate locking screw failure during surgery
FDA (Devices) · 2025-03-05
- HighOrthopedic Surgical Plates Recalled Due to Intra-Operative Locking Screw Malfunction
FDA (Devices) · 2025-03-05
- HighAnatomic Lateral Fibula Plate locking screw malfunction during surgery
FDA (Devices) · 2025-03-05