Recall Z-1607-2020 ยท HWC Screw, Fixation, Bone
Trilliant Surgical, LLC
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.
| Date | Jul 19, 2018 |
| Status | Terminated |
| Reason | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. |
| Root cause | Labeling Change Control |
| Action | The recalling firm issued letters as of 7/19/2018 via FedEx. |
| Quantity | 4 systems total for both Twist Sublatar and Disco Sublatar |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103183 | TRILLIANT SURGICAL SUBTALAR IMPLANT Trilliant Surgical, Ltd., Feb 8, 2011 |