FDA (Devices) recall action 84977

Trilliant Surgical, LLC recalled 10 products on 2020-04-08

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2020-04-08
Critical: 0
Units: 249

Why these products were recalled

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–10 of 10

ModerateFDA (Devices)··2020-04-08
Trilliant Surgical Recalls Instructions for Use for Tiger Screw Systems
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for Tiger Cannulated Screw Systems to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant…
Category
Distribution
29 states
ModerateFDA (Devices)··2020-04-08
Trilliant Surgical Disco Subtalar Implant Instructions for Use Recall
Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Disco Subtalar Implant System to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
Category
Distribution
29 states
ModerateFDA (Devices)··2020-04-08
Trilliant Surgical Small Joint Reaming System Instructions for Use Recall
Trilliant Surgical LLC is recalling Instructions for Use and Cleaning Protocols for the Small Joint Reaming System to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
Category
Distribution
29 states
ModerateFDA (Devices)··2020-04-08
Trilliant Surgical Twist Sublatar Implant System Instructions for Use Recall
Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Twist Sublatar Implant System to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
Category
Distribution
29 states
ModerateFDA (Devices)··2020-04-08
Trilliant Surgical Gridlock Ankle Plating System Instructions for Use Recalled
Trilliant Surgical LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Gridlock Ankle Plating System to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Ankle Plating System, Model 320-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
Category
Distribution
29 states
ModerateFDA (Devices)··2020-04-08
Trilliant Surgical Recalls Hammertoe Implant Instructions for Use
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for its Two-Step Hammertoe Implant System to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
Category
Distribution
29 states
ModerateFDA (Devices)··2020-04-08
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.
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.
Category
Distribution
29 states
ModerateFDA (Devices)··2020-04-08
Trilliant Surgical Recalls Instructions for Use for Tiger Screw Systems
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for Tiger Screw Systems to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combination Tiger Cannulated/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name…
Category
Distribution
29 states
ModerateFDA (Devices)··2020-04-08
Trilliant Surgical Gridlock Plating System Instructions for Use Recall
Trilliant Surgical is recalling Instructions for Use and Cleaning Protocols for the Gridlock Plating System to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
Category
Distribution
29 states
ModerateFDA (Devices)··2020-04-08
Trilliant Surgical Recalls Instructions for Use for Cannulated Screw Systems
Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for two cannulated screw systems to update dry time parameters.
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless Screw System, Model 215-00-001. The firm name on the…
Category
Distribution
29 states