FDAFDA · Food and drugs·Recall number Z-1608-2020
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.
Published April 8, 2020 · Recall initiated: July 19, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Trilliant Surgical, LLC
- Distributor
- 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.
- Lot
- IFUs previous to Document #900-01-005 Rev. N and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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