Trilliant Surgical 3S Hemi Toe Implant Instructions for Use Recall
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for the 3S Hemi Toe Implant System to update dry time parameters.
What this means for you
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 involves updated documentation for dry time parameters without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Trilliant Surgical, LLC is recalling the Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols for the 3S Hemi Toe Implant System, Model 111-00-001. The recall involves 9 systems and affects documentation versions prior to Document #900-01-009 Rev. I and Document #900-06-008 Rev. H.
The recall was initiated to update the documents with revised dry time parameters. The source text notes that this recall of the IFU occurred in 2018.
The affected documentation was distributed to 29 US states and Puerto Rico, as well as to Australia, India, Italy, Panama, and Turkey. The distribution included government channels but no military distribution. Users should refer to the updated documents for the correct dry time parameters.
The recalled product
- Product
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
- Manufacturer
- Trilliant Surgical, LLC
- Hazard
- Affected units
- 9
Distribution
Part of a larger recall action
This product is one of 10 recalled by Trilliant Surgical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · Trilliant Surgical, LLC
See all →- ModerateTrilliant Surgical Recalls 3.5mm Aresenal Screw Drill Bits Due to Labeling Error
FDA (Devices) · 2020-05-13
- ModerateTrilliant Surgical Recalls 8mm Hammer Toe Reaming Kits Due to Incorrect Contents
FDA (Devices) · 2020-04-08
- ModerateTrilliant Surgical Recalls Instructions for Use for Cannulated Screw Systems
FDA (Devices) · 2020-04-08
- ModerateTrilliant Surgical Recalls Instructions for Use for Tiger Screw Systems
FDA (Devices) · 2020-04-08
- ModerateTrilliant Surgical Gridlock Plating System Instructions for Use Recall
FDA (Devices) · 2020-04-08
Same hazard · documentation error
See all →- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
- ModeratePower Over Fiber Base Modules Recalled Due to Incorrect Laser Classification and Labeling
FDA (Devices) · 2026-08-05
- ModerateEmbrace standard drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- ModerateEmbrace shoulder drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01