Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant Surgical, Houston, TX.
This recall has been terminated (originally issued July 19, 2018).
- Company
- Trilliant Surgical, Llc
- Recall Initiated
- July 19, 2018
- Recall Number
- Z-1605-2020
- Quantity
- 170 systems
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
IFUs previous to Document #900-01-002 Rev. P and Cleaning and Sterilization Protocols previous to Document #900-06-007 Rev. F.
Root Cause
Labeling Change Control
Action Taken
The recalling firm issued letters as of 7/19/2018 via FedEx.
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