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Terminated

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.

FDA Recall Z-1610-2020 · Posted None

Recalling FirmTrilliant Surgical, LLC
Recall StatusTerminated
Product CodeHWC
Date Initiated2018-07-19
Product Quantity17 systems

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.

Firm Action

The recalling firm issued letters as of 7/19/2018 via FedEx.

Root Cause

Labeling Change Control

Distribution Pattern

Distribution to US states: AZ, CA, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, MO, MT, ND, NE, NH, NJ, OH, OK, PA, SD, TN, TX, VA, WA, WI, WY, and PR. There was government distribution and no military distribution. Foreign distribution to Australia, India, Italy, Panama, and Turkey.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122959HAMMER TOE IMPLANTTrilliant Surgical, Ltd. · 2012-11-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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