Recall Z-1614-2020— Trilliant Surgical, LLC

Name: FDA recall Z-1614-2020
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. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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

Product description

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.

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.