Recall Z-0799-2020 ยท HXX Screwdriver
Trilliant Surgical, LLC
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
| Date | Mar 14, 2019 |
| Status | Terminated |
| Reason | A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended. |
| Root cause | Process control |
| Action | The recall strategy included sending written recall communication and response forms as of 03/14/2019 via FedEx (Express Standard Overnight) to all consignees that showed possession / had been sold a device (as the device is considered reusable) as of 03/14/2019. The communication instructed the consignees to: " Check inventory stock for identified devices " Locate and remove and/or discontinue use of identified devices " Return all related product(s) to Recalling Firm in accordance with the included return response / acknowledgement form. |
| Quantity | 20 units |
| Distribution | US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.