Recall Z-1610-2020— Trilliant Surgical, LLC

Name: FDA recall Z-1610-2020
Creator: U.S. Food and Drug Administration
Published: 2018-07-19

Class II · Terminated

Class II FDA medical device recall by Trilliant Surgical, LLC, initiated 2018-07-19. It names one FDA 510(k) clearance: K122959. 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.. Reason: Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018..

Recalling firm: Trilliant Surgical, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-07-19
Firm location: Houston, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K122959 — HAMMER TOE IMPLANTTrilliant Surgical, Ltd.·cleared 2012-11-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.