Z-1607-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- July 19, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 systems total for both Twist Sublatar and Disco Sublatar
Product Description
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.
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 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.
Code Information
IFUs previous to Document #900-01-003 Rev. M and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C.